Improving Oral Contraceptives Encouraging Research Into Oral Contraceptives and Their Side Effects
A Major Qualifying Project completed in partial fulfillment of the Degree of Bachelor of Science at WORCESTER POLYTECHNIC INSTITUTE
Submitted 6 April 2021
Author: Yvonne Niebuhr
WPI Faculty Advisor: Professor Crystal Brown
This report represents the work of one or more WPI undergraduate students submitted to the faculty as evidence of completion of a degree requirement. WPI routinely publishes these reports on the web without editorial or peer review. Abstract
A wide range of side effects worsen many people’s experiences with oral contraceptives. These side effects are largely underresearched, leading to a lack of knowledge in the medical community about how to address them. This project not only encourages research into oral contraceptives and their side effects, but also serves as a blueprint for a study structure that could be replicated and further developed by future researchers. Through design and use of an online survey, data was collected on over 300 participants’ experiences with oral contraceptives. This data was used to compare brands of oral contraceptives according to what side effects survey participants reported experiencing while using them. A Side Effects Troubleshooting Tool
(SETT) was also designed as part of the project using this data. This tool is provided as a resource for patients, a reference for healthcare providers, and a blueprint for future research and development. This project made a step toward addressing the side effects of oral contraceptives by listening to the experiences of people who have used oral contraceptives, conducting initial research into the problem, and encouraging further research to improve experiences with oral contraceptives for all. Table of Contents
Abstract 2 Table of Contents 3 Introduction 5 A Note About Gendered Terminology 5 Literature Review 6 What Are Oral Contraceptives? 6 Problems in the Contraceptive World 6 Side Effects 6 Potential Determinants of Side Effects. 8 Venous Thromboembolism and the Pill Scare 8 Continuation over Information 9 Research Gaps 10 Silencing Women 12 Addressing the Problem 13 Conclusion to the Literature Review 14 Methodology 15 Introduction to the Methodology 15 Literature Review 15 Survey 16 Design 16 Distribution 17 Protecting Respondent Information 18 Using Survey Results 18 Results 18 Demographics 19 First Brand of OC 21 Second Brand of OC 27 Third Brand of OC 32 Fourth Brand of OC 35 Experience with Healthcare Professionals 35 Ranking Brands by Side Effects Experienced 38 Top 20 39 Bottom 20 40 Adjusted Top 20 41 Adjusted Bottom 20 42 The Side Effects Troubleshooting Tool (SETT) 43 Discussion 46 High Occurrence of Side Effects and Discontinuation 47 Why Focus on Brands? 47 Purpose of SETT 49 Resource for Patients 50 Blueprint for Research 50 Reference for Healthcare Providers 51 Conclusion 51 References 54 Appendix A 58 Appendix B 68 Introduction
People around the world reap the benefits of oral contraceptives every day. For the sixty year history of oral contraceptive (OC) use in the United States, however, people have also had to experience the drawbacks of OC side effects. These side effects include both physical and mood symptoms across a range of mild to severe to even death in some cases. While there have been improvements in OC safety over time, the mission to solve the side effects problem is far from over. People are expected to deal with side effects in order to prevent unplanned pregnancies and address other medical needs. Research on OCs is lacking, and the resulting lack of research-based knowledge prevents further advancement. Much of the research that does exist has a shady past of sidestepping informed consent and ignoring women’s concerns. More research into OCs and their side effects is necessary in order to protect the health and safety of people who use them. This research must actively seek out and recognize people’s lived experiences in order to create a patient-centric progression of OC improvement. This project contributes to this progression by collecting information from people about their own experiences with OCs, and proposes how future researchers should adapt the methods to further studies that can benefit a wide range of people. So many people depend on OCs for reproductive autonomy and meeting their medical needs, and they should be able to depend on OCs to keep them healthy and safe as well.
A Note About Gendered Terminology
This project recognizes that not all people who use or have used oral contraceptives identify as women. Effort has been made throughout this paper to use gender-neutral terminology when possible.There are some points, especially when past research in the literature is mentioned, that “woman” or “women” specifically has been written. However, this project is designed to benefit people of all gender identities, and encourages all future researchers to design their projects to benefit people of all gender identities as well.
Literature Review
What Are Oral Contraceptives?
Oral contraceptives, also known as birth control pills or simply “the pill,” help people worldwide to take control of their own reproductive systems. In the United States, 12.6% of women between 15 and 49 years old use an OC pill (Daniels & Abma, 2018). OCs work by using hormones called progestin and estrogen to prevent ovulation (Liao & Dollin, 2012).
Preventing ovulation means that the body does not release an egg, and as a result any incoming sperm will be unable to fertilize an egg and no pregnancy occurs (Hill, 2019). Since the pill’s introduction in 1960, the dosages of progestin and estrogen have changed, but the strategy remains: since the body does not release an egg, the body does not get pregnant (Liao & Dollin,
2012). The process of changing these dosages, however, has historically occurred as a response to negative side effects that harmed the people who used OCs. This project aims to address that harm and prevent additional harm from occurring in the future.
Problems in the Contraceptive World
Side Effects
The side effects associated with taking an oral contraceptive are numerous and unsettlingly common. In a study published in Contraception, 77% of participants experienced at least one side effect while taking an OC (O’Connell et al., 2007). Some side effects include breakthrough bleeding, nausea, fluid retention, increased vaginal discharge, depression, acne, loss of libido, vaginal dryness, menstrual irregularity, weight gain, and ovarian cysts
(MacGregor, 2017; O’Connell et al., 2007). Some of these side effects may be addressed by changing the specific type of pill that a patient is taking (MacGregor, 2017), however a patient often must first experience a negative side effect before bringing that concern to a doctor to troubleshoot the problem. More concerning but fortunately less common risks associated with
OCs include venous thromboembolic disease (VTE), arterial thromboembolism, and possibly breast, cervical, and other cancers (MacGregor, 2017). These physical symptoms are relatively well-discussed throughout the medical community.
Emotion-related symptoms, on the other hand, are painfully less addressed. One study from the Nordic Federation of Societies of Obstetrics and Gynecology phrases the problem well by stating that “surprisingly little is known about the prevalence of truly COC[combined oral contraceptive]‐related adverse mood symptoms and about the underlying biological mechanisms of proposed changes in mood and affect” (Poromaa & Segebladh, 2011). Some of these emotion-related or mood side effects include mood swings, irritability, and depressive symptoms
(Poromaa & Segebladh, 2011). Across several studies, it appears that about 2-16% of women taking OCs experience negative mood side effects, with some variation based on the type of mood symptom and the type of OC (Poromaa & Segebladh, 2011). Another study places the rate of mood side effects, particularly in young minority women, in a higher range of 19-25% of women (Hall et al., 2012). A study involving minority adolescents found that in addition to the previously mentioned mood symptoms, eating disorder symptoms affected nearly 10% of subjects (Hall et al., 2011). These percentages must not be ignored.
One reason why the medical community is unsure and under-informed about mood side effects is because, unlike physical symptoms, mood symptoms are subjective and more challenging to quantify (Poromaa & Segebladh, 2011). Also, any studies researching these symptoms may have inaccurate results because people drop out of the studies due to the very side effects being researched (Poromaa & Segebladh, 2011). As a result, the numbers for people experiencing mood symptoms are likely even higher than what the literature suggests (Poromaa
& Segebladh, 2011). The medical research community needs to take these concerns into account and conduct further research studying both physical and emotion-related side effects of OCs.
Potential Determinants of Side Effects.
Variation between any two women’s experiences of OC side effects is common, and even the norm (Hill, 2019). Research into factors that may cause one person rather than another to experience a particular side effect is extremely limited. In the course of collecting literature for this review, however, one potentially promising genetic factor associated with OC side effects appeared. A 2009 study on SSRIs, a form of antidepressant treatment, found that women with a certain genotype of the 5HTTLPR gene, ll, were about eight times more likely to experience sexual dysfunction if they were taking an OC along with SSRIs as opposed to women taking
SSRIs without taking an OC as well (Bishop et al., 2009). This study suggests that at least one genetic factor may be, in some cases, a potential determinant of OC side effects. More research on this topic is needed.
Venous Thromboembolism and the Pill Scare
Venous thromboembolism (VTE) is one of the more researched physical side effects of
OCs, but this was not always so. In 1995, researchers found that some types of OCs could increase a patient’s risk of VTE, a condition characterized by blood clots in the legs that could result in death (Furedi, 1999). The announcement of these findings was released to both medical professionals and the press at the same time, causing many women taking these pills to panic before their doctors even received the news (Furedi, 1999). This panic and the reduction in OC consumption that followed is referred to throughout the literature as the “pill scare” (Furedi, 1999). Oral contraception use fell from 40 to 27% within a year, and unplanned pregnancies increased accordingly (Furedi, 1999). OCs have been updated since the pill scare, but there is still some disagreement in the medical research community about whether newer forms of OCs decrease, increase, or do not change the level of VTE risk associated with the OCs available during the pill scare (Heinemann et al., 2010; Plu-Bureau et al., 2013). The pill scare’s resulting unplanned pregnancies and the costs associated with them caused many in the medical community to pursue more careful ways to communicate side effects with their patients (Furedi,
1999). This focus on careful communication may have gone too far, however, in that some members of the medical community have prioritized OC continuation over keeping patients thoroughly informed and healthy.
Continuation over Information
A blatant example of this prioritization taken too far can be found in a paper published in
Contraception (Grimes & Schulz, 2011). The authors argue that side effects are the most common reason for discontinuation of OCs, and since discontinuation is associated with a rise in unplanned pregnancies, the medical community must address the side effects problem in order to reduce discontinuation and unplanned pregnancies (Grimes & Schulz, 2011). While that argument matches many others throughout the literature, the authors’ solution plan expressed later in the paper does not. The authors utilize charged language to call women’s concerns about side effects “an elaborate mythology… fueled by rumor, gossip, and poor-quality research”
(Grimes & Schulz, 2011). They assert that there is not sufficient evidence for women’s experience of side effects (Grimes & Schulz, 2011), either contradicting or ignoring the literature referenced throughout this review. They explain the prevalence of side effects as a result of the nocebo effect and “the power of suggestion” (Grimes & Schulz, 2011). The claims these authors make not only lack concordance with much of the available literature, but are also dangerous to women because of the conclusion the authors draw by the end of the paper: Since women experience side effects because their knowledge of side effects causes them to experience the nocebo effect, medical professionals should not inform women of side effects at all (Grimes &
Schulz, 2011). This conclusion is dangerous because it contradicts the idea that people have the right to know what they put inside their bodies and how it will affect them. While side effects are clearly a problem in the world of oral contraception, the solution lies in addressing the side effects, not ignoring them.
Other sources demonstrate a prioritization of contraceptive continuation, though not to such a drastic degree. Improving oral contraception continuation is absolutely a valuable goal.
Since thorough research into fixing the side effects of oral contraception is in low supply, many professionals see finding ways to encourage continuation as the next best option. A 2013 paper recognizes side effects as the second most common reason for discontinuation, and reports that
51% of women experience at least one side effect when taking birth control (Castaño & White,
2013). The authors recommend changing birth control methods as a management strategy for side effects (Castaño & White, 2013). However, the authors state that “there are few evidence-based changes to OC regimens that can be done to improve side effects” (Castaño &
White, 2013). The paper demonstrates that there is too little knowledge in how to help people when their OCs are harming them.
Research Gaps
Many unknowns exist in the world of OCs. Research has helped solve some of these unknowns, but countless questions remain. A paper published in Contraception outlines specific gaps in contraceptive research with several subtopic research suggestions within each gap (Horton et al., 2016). These gaps were identified by the Centers for Disease Control and
Prevention (CDC) in order to develop the US Medical Eligibility Criteria for Contraceptive Use
(US MEC) (Horton et al., 2016). The two major research gaps highlighted in the paper relevant to this project are progestin-only pills and combined OCs (Horton et al., 2016). Subtopic suggestions under progestin-only pills include research involving breastfeeding, obesity, VTE and VTE risk factors, cystic fibrosis, and multiple sclerosis (Horton et al., 2016). Subtopic suggestions under combined OCs include obesity, cardiovascular disease risk factors, dyslipidemia, and multiple sclerosis (Horton et al., 2016).
Part of the reasons why research on OCs is currently so lacking is that the US MEC was not developed until 2010 (Horton et al., 2016). Guidelines and policies surrounding contraceptive research are still in the emerging stage. Although OCs have existed for more than half a century, policies intended to protect the people who take them are still extremely limited.
Even with the introduction of the US MEC in 2010 and its counterpart the US Selected Practice
Recommendations for Contraceptive Use (US SPR) in 2013, these guidelines were missing the previously mentioned research gaps, and were updated to include them between 2014 and 2015
(Horton et al., 2016). Given the amount of time it may take for research to translate into better products and policies, it is not much of a surprise that the research gaps highlighted in the US
MEC and US SPR have not yet been filled in 2021. There are also research gaps not included in the US MEC and US SPR, such as research into the mood side effects mentioned previously in this review. In fact, the lack of attention to mood side effects in these guidelines follows the historically evident practice of the medical community deemphasizing mood side effects, in part due to a sexist belief that “emotional” evidence from women is an inherently less valuable form of evidence (Kline, 2010). Silencing Women
The history of OC development displays a distressing trend of ignoring people’s negative experiences with OCs. This trend dates as far back as 1956, when the first large-scale trial of
OCs occurred in Puerto Rico due to restrictive US laws that prevented this type of research within the States (Liao & Dollin, 2012). The researchers did not provide adequate information about the safety and risks of the OC to the women involved, creating a lack of informed consent for the subjects of the study (Liao & Dollin, 2012). The researchers also dismissed any woman who reported side effects such as blood clots, headaches, dizziness, and nausea as “unreliable historians” (Liao & Dollin, 2012). The history of OCs began with ignoring women, and this was certainly not the last time the medical community would silence people with these experiences.
In the 1960’s, women’s distrust in the medical community grew (Lackie & Fairchild,
2016). In 1969, Barbara Seaman published The Doctor’s Case Against the Pill, admonishing the medical community for hiding the dangers of OCs from women (Lackie & Fairchild, 2016).
United States Senator Gaylord Nelson used this book and the ideas provided within to advance his goal of informed consent laws for OCs at subcommittee hearings in 1970 (Lackie &
Fairchild, 2016). Unfortunately, Nelson neglected to invite any women to the hearings (Lackie &
Fairchild, 2016). Barbara Seaman was excluded from the hearings inspired by her own work, and any women with negative OC experiences were excluded as well (Lackie & Fairchild, 2016).
While Nelson’s original goal was laudable, his exclusion of women was not.
The Nelson hearings were far from the only time that women have been locked out of contraceptive law. In 1983, a series of FDA hearings were conducted in response to
Depo-Provera, an injectable contraceptive with dangerous side effects (Kline, 2010). The medical community’s push for the unsafe Depo-Provera, particularly in Black communities, sparked “concern about racist population control policies, and also drew attention to poor scientific research methods” (Kline, 2010). As the hearings were being organized in 1978,
Upjohn, the company responsible for Depo-Provera, appealed the FDA to “prevent consumer and feminist activists” from speaking at the hearings, explaining that these activists could not be considered “expert witnesses” (Kline, 2010). While Upjohn’s appeal was unsuccessful, it highlighted the pharmaceutical industry’s disregard for women’s lived experiences, a problem that persists today. The medical community will not be able to fully fix the side effect problem until the people using OCs and their experiences are prioritized.
Addressing the Problem
The advancement of OC safety runs far behind where it should be. The medical community’s persistent failure to sufficiently protect women has roots in a history of ignoring and under-informing them. A 2019 paper phrased the problem well by stating: “Unintended pregnancy rates will remain high until researchers explore the lived experience of women's relationships with contraception” (Alspaugh et al., 2019). The medical community should not expect people to simply tolerate the numerous side effects associated with OCs. Instead, the medical community needs to listen to people using OCs and their concerns in a consistent effort to improve OC products through thorough and ethical research.
The need for patient-centric research in the OC field must be addressed. This project took a step toward addressing that need by reaching out to people who have used OCs and listening to their lived experiences. An online survey was used in order to obtain this information efficiently and effectively. Included in the survey were questions about what specific types of OC people have used, what side effects they experienced while taking them, whether they switched to another form of OC and/or discontinued OC use altogether, and if that switch removed the side effects as desired. The survey also included questions about respondents’ experiences with their healthcare providers.
Survey data was used to inform the project, create rankings of OC brands based on side effects reported, and create a Side Effects Troubleshooting Tool (SETT). SETT is an interactive dataset where viewers can see side effects that respondents have experienced with certain OC brands, what brand respondents switched to, and if the brand switch was effective in removing the side effect. This resource can help people taking OCs place themselves at the center of their own health and OC experiences, as well as serve as a reference for healthcare providers helping patients through the OC experience. Additionally, the survey structure and SETT were designed to be used as a blueprint for further research that can involve, educate, and assist a greater population in taking control of their own health and safety.
Conclusion to the Literature Review
Oral contraceptives are an incredibly useful resource. After over sixty years of OC development, however, useful is not enough. People taking OCs need safety as well. While improvements in the safety of OCs have occurred over time, the process of addressing OC side effects still has a long way to go. It is imperative that people’s lived experiences stand at the forefront of OC development efforts. Members of the medical community have swept concerns about OC side effects under the rug for too long, and some continue to do so today. Only through listening to people who have used OCs and understanding their experiences can the medical community sufficiently address side effects and achieve widespread OC continuation. This project took a step toward achieving the goal of increasing the medical community’s knowledge of people’s experiences with OCs, and advancing toward a world in which people no longer have to choose between reproductive autonomy and their own safety. Methodology
Introduction to the Methodology
There is not enough research into the harmful side effects of oral contraceptives (OCs) and how to address these side effects. This project made a step in addressing this problem by collecting a sample of people’s experiences with OCs and their side effects. The goal of this project was to improve OCs through encouraging increased medical research into their side effects, as well as conducting initial original research into this matter. Through the use of a survey, people had the opportunity to share their experiences with OCs, including their experiences with side effects and experiences with their healthcare providers. Survey participants were assured and confirmed that all responses were anonymous and voluntary. Survey responses were used to inform the project, rank OC brands according to side effects reported, and design the Side Effects Troubleshooting Tool (SETT).
Looking ahead, the methods of collecting and displaying survey data used in this project could be adopted by medical research organizations in order to hold studies of larger scale. The results of these studies could be used to create a more comprehensive dataset that could be used in healthcare settings by providers assisting their patients in making more informed health decisions, or used to drive research into addressing the concerns highlighted in the dataset.
Literature Review
The initial step of this project was to craft a literature review. The literature review serves as a compilation of information describing OCs, their side effects, and the medical research surrounding OCs historically and into the present. Sources for the literature review were found through Worcester Polytechnic Institute’s Library Search. Databases containing the sources used included Gale Academic Onefile, JSTOR, Oxford Academic, Project MUSE, PubMed Central,
SAGE Journals, ScienceDirect, and Wiley Online Library.
One of the central takeaways of the literature review was that much of OC research has historically been characterized by medical and legal communities dismissing women’s concerns about and experiences with OC side effects. This project aimed to help remedy this dismissal by asking people who have used OCs directly about their experiences. This communication took place in the form of an online survey.
Survey
Design
The survey was designed using Qualtrics. It began with a short statement describing the project and the survey, and notified the participant that all responses are voluntary and that their responses would remain anonymous. Demographic data collected in the survey included age, gender identity, and what state the participant was located in. This survey was limited to participants located in the United States in order to ensure that survey responses pertained to the
United States healthcare system.
The survey then asked if the participant had used an oral contraceptive. If the participant responded yes, the survey continued on to a section that asked about brands of OC used, age of participant when using, reasons for use, side effects experienced, and how many months the participant used a brand of OC. If the participant had discontinued use, the survey asked about reasons for discontinuation and what form of contraception the participant now uses. If the participant moved onto a different OC, the survey asked the same questions about the second OC as the first OC, and the cycle continued until the participant had reported on all brands of OC that they have used. The purpose of this section was to serve as the basis for SETT, the dataset of respondents’ experiences with OCs and side effects.
After the section about OC brands, the survey displayed a matrix table with seven statements about the participant’s experiences with healthcare providers in respect to OCs. The participant could then respond to what extent they agree or disagree with each statement. There was also an option for the respondent to select that a statement “Does not apply.” The purpose of this section was to gain information on if people who used OCs felt adequately informed and listened to by medical professionals.
The final section of the survey included two text entry free response questions: one that asked for any additional comments about experiences with side effects, and one that asked the same about experiences with healthcare providers. This section allowed participants to share any thoughts that the previous questions of the survey did not allow for.
A copy of the survey can be found in Appendix A.
Distribution
The survey was distributed online to individuals over the age of 18. In order to test the survey, the survey was first distributed to a small group of known potential respondents for feedback. Once these initial respondents had completed the survey and feedback had been addressed, an improved final survey was created and full survey distribution began. The survey was distributed by sharing a link to the survey through various formats such as email, text messaging, and social media. Participants also had the option to distribute the survey link. Protecting Respondent Information
The Qualtrics “Anonymize Response” option was activated for this survey in order to protect respondents’ personal information. This option caused the survey to not record any personal information and removed contact association.
Using Survey Results
When all responses were collected and the survey was closed, survey responses were compiled into a SETT, a dataset that can be searched by brand of OC. When a viewer of SETT selects an OC brand, they will be able to see the side effects experienced by respondents who have taken that OC, and how common those side effects are among respondents. The viewer will also be able to see what steps the respondent took to address the side effects, and if these steps were effective. The purpose of SETT is to give the viewer a clearer picture of options and expectations for their OC experience. SETT is not official medical data and should only be used for educational purposes. SETT will be useful as an educational tool because viewers will have the opportunity to gain additional, more personal perspectives on OC experiences that they would not otherwise have access to. Survey responses were also used to create rankings of OC brands based on side effects reported.
Results
This section describes the results of the oral contraceptives (OCs) survey. There were a total of 344 respondents to the survey, but 14 responses were deleted due to these respondents being under the age of eighteen. Without those respondents, there was an adjusted total of 330 survey respondents. All survey questions were optional, so the number of respondents per question varies. Demographics
The first section of the survey, after respondents consented to proceed with the survey, asked a series of questions about respondent demographics. Respondent age ranged from ages 18 to 52, with most respondents being in their late teens and early twenties.
Figure 1. Age of respondents.
Respondents selected their gender. Most respondents identified as “Woman” (n=296), while some identified as “Nonbinary person” (n=9), “Man” (n=6), or “Other” (n=4).
Respondents also selected what state they were currently living in. Respondents from 27 states were represented in this survey, with the majority of respondents located in Massachusetts
(n=223). Figure 2a. Distribution of respondents across states. Figure 2b. Map of states in which respondents were living.
First Brand of OC
The next section of the survey asked respondents about experiences with their first brand of OC. A total of 281 respondents selected a first brand. Excluding “Do not know / Do not remember” (n=47) and “Other” (n=45), the top five first brands selected were as follows:
Junel® Fe (n=23), Sprintec® (n=19), Loestrin® Fe (n=17), Apri® (n=11), and Tri-Sprintec®
(n=10).
Respondents were then asked at what age they began using their first brand. Responses ranged from age 12 to age 42, with most responses in the range of early teens to early twenties. Figure 3. Age at which respondents began using the first brand of OC.
The next question asked respondents their reason(s) for using their selected first brand of
OC. The most common reason for use was relief from menstruation symptoms (n=182), with the second most common reason being to prevent pregnancy (n=161). Figure 4. Reason(s) for using the first brand of OC.
Respondents then reported side effects they experienced while using their first brand. Out of the 281 respondents who selected a first brand, a total of 140 respondents (49.8%) reported experiencing mood swings, along with 121 reports (43.1%) of depressive symptoms and 120 reports (42.7%) of irritability. Other side effects reported included fluid retention, nausea, bleeding, eating disorder, ovarian cysts, and breast cancer. Figure 5. Side effect(s) experienced while using the first brand of OC.
The next question asked respondents for how many months they used the first brand of
OC. This question had 269 responses. The majority (n=181) (67.3%) of respondents used their first brand for 12+ months, though 70 respondents (26.0%) used their first brand for six months or less. Figure 6. Number of months (1-12+) for which respondents used their first brand of OC.
When asked if they are currently using their first selected brand of OC, about half of respondents reported still using their first brand (50.6%), while the other half reported not currently using their first brand (49.4%). Out of the respondents not currently using their first brand, the most common reason for discontinuation was that the respondent experienced side effect(s) (n=75). Figure 7. Reason(s) for discontinuation of first brand of OC
Respondents who discontinued use of their first brand were then asked if they switched to a different brand of OC. Out of 133 responses to that question, 81 respondents (60.1%) reported switching to a different brand of OC after discontinuing use of their first brand.
Out of respondents who discontinued use of their first brand and did not switch to another brand of contraceptive, most (n=26) reported switching to long-acting reversible contraception.
Other methods used included barrier methods (n=12), no contraception (n=12), hormonal methods (n=7), and emergency contraception (n=2).
Respondents who switched to another brand of OC were asked if their next brand of OC removed the side effects they experienced with the previous brand. Options presented to the respondent were “Yes,” “Yes, but I experienced new side effects,” “No,” and “I did not experience side effects with the previous brand.” Responses were nearly evenly split between the first three options, with a lower quantity of respondents reporting not experiencing side effects with their previous brand.
Figure 8. Responses to “Did the next brand you tried remove the side effects you experienced
with the previous brand?”.
Second Brand of OC
The next section of the survey asked respondents about their experiences with the second brand of OC that they tried. 91 respondents selected a second brand. Excluding “Other” (n=22) and “Do not know / Do not remember” (n=10), the top five second brands selected were as follows: Sprintec® (n=8), Loestrin® Fe (n=5), Tri-Previfem® [DSC] (n=5), Junel® (n=4), and
Norethidrone® (n=4). Respondents began using their second brand between the ages of 14 to 32, with most respondents (92.3%) answering in the 16 to 22 range. Figure 9. Age at which respondents started using their second brand of OC.
The distribution of reasons for using the second brands was similar to that of the first brands.The top reason for use was relief from menstruation symptoms (n=63), with the second most common reason for use being to prevent pregnancy (n=54). Other reasons for use included to treat acne (n=26), treat endometriosis (n=6), and reduce cancer risk (n=3).
Respondents were then asked about side effects they experienced while using their second brand. Out of the 91 respondents who selected a second brand, a total of 37 respondents
(40.7%) experienced mood swings, 33 respondents (36.3%) experienced irritability, and 31 respondents (34.1%) experienced depressive symptoms. Other side effects experienced during use of the second brand included nausea (n=25), fluid retention (n=25), bleeding (n=19), eating disorder (n=6), ovarian cysts (n=3), and breast cancer (n=1). Figure 10. Side effects respondents experienced while using their second brand of OC.
The next question asked respondents for how many months they used their second brand.
This question had 87 responses. Similar to how long respondents used their first brand for, the majority (n=47) (54.0%) of respondents used their second brand for 12+ months. A total of 28 respondents (32.2%) used their second brand for six months or less, however, which is a slightly higher percentage than respondents using their first brand. Figure 11. Number of months (1-12+) for which respondents used their second brand of OC.
When asked if they were currently using their second brand, 57.5% (n=50) responses to the question were yes, while the remaining 42.5% of respondents (n=37) were not still using their second brand. Respondents who had discontinued use of their second brand were asked their reasons for discontinuation. Similar to those who had discontinued use of their first brand, the most common reason for discontinuation of the second brand was the experience of side effects (n=24). Other reasons for discontinuation included logistics (n=6), fear of side effects not experienced (n=2), and fertility (n=2). Figure 12. Reasons for discontinuation of second brand of OC.
Respondents who discontinued their second brand were then asked if they switched to a different brand of OC. Out of the 36 respondents who answered that question, there was a 50-50 split (18 yes, 18 no) between those who switched to a different brand and those who did not.
Respondents who did not switch to a different brand of OC were asked what form of contraception they use now. Most (n=10) use long-acting reversible contraception. Other methods include hormonal methods (n=4), no contraception (n=3), barrier methods (n=2), and emergency contraception (n=1).
Respondents who switched to another brand of OC after discontinuing their second brand were asked if the next brand they tried removed the side effects they previously experienced. A majority (n=12) (66.7%) of respondents who answered the question replied “Yes” . One respondent answered “Yes, but I experienced new side effects,” four respondents answered “No,” and one other respondent answered “I did not experience side effects with the previous brand.” Figure 13. Responses to “Did the next brand you tried remove the side effects you
experienced with the previous brand?”.
Third Brand of OC
The next section of the survey asked respondents about their experiences with the third brand of OCs that they tried. 14 respondents selected a third brand. 5 of those respondents selected “Other” as their third brand. 2 respondents selected Kariva®, and 1 respondent each selected Camrese®, Errin®, Norethidrone®, Sronyx®, Tri-Sprintec®, Yasmin®, and “Do not know / Do not remember.” Respondents were between the ages of 18 to 23 when they began using their third brand. Figure 14. Age at which respondents began using their third brand of OC.
Reasons for using the third brand followed the pattern of the first and second, with relief from menstruation symptoms as the most common reason (n=10) and pregnancy prevention as the second most common reason (n=8).
Figure 15. Reasons for using the third brand of OC. The most common side effect experienced while using the third brand was depressive symptoms (n=4). Other side effects included mood swings (n=3), irritability (n=2), nausea
(n=1), and fluid retention (n=1).
Figure 16. Side effects experienced while using the third brand of OC.
Similar to the first and second brands, the majority of respondents (61.5%) (n=8) used their third brand for 12+ months. A total of 4 respondents (30.8%) used their third brand for six months or less. The remaining 1 respondent used their third brand for 8 months. Most respondents (85.7%) (n=12) who selected a third brand are currently using that brand. The remaining 2 respondents discontinued use of their third brand.
Out of the respondents who discontinued use of their third brand, one responded with experience of side effects as their reason for discontinuation, while the other selected “Other” as their reason and referenced struggles with their pharmacy in their description. Both respondents switched to another brand of OC after discontinuing their third brand. When asked if their next brand removed the side effects they experienced with their third brand, one respondents selected “Yes, but I experienced new side effects.” The other respondent selected “I did not experience side effects with the previous brand.”
Fourth Brand of OC
A total of 2 respondents selected a fourth brand of OC. Both selected “Other.”
Respondents started use of their fourth brand at ages 19 and 21. Reasons for use included relief from menstruation symptoms (n=2) and pregnancy prevention (n=1). Side effects experienced while using the fourth brand included bleeding (n=1). One respondent had been using their fourth brand for 1 month, and the other had been using theirs for 2 months. Both respondents are still currently using their fourth brand.
No survey respondents had tried five or more brands of OC.
Experience with Healthcare Professionals
Respondents were then asked about their experiences with their healthcare professionals relevant to OCs. All statements began with “To what extent do you agree with the following statements: ‘My doctor(s)/ prescriber(s)/ healthcare professional(s)...’.” Respondents could then indicate on a five-point scale from “Strongly agree” to “Strongly disagree” how much they agreed with the statement. Respondents could also select “Does not apply.”
The first statement, “Offered me enough information on the different types of birth control,” had 244 responses. 48.8% of respondents answered “Strongly agree” or “Agree,” while
30.7% answered “Strongly disagree” or “Disagree.”
The second statement, “Offered me enough information on the different types of OCs,” had 243 responses. 30.9% of respondents answered “Strongly agree” or “Agree,” while the majority (54.7%) answered “Strongly disagree” or “Disagree.” The third statement, “Listened to and understood my concerns about side effects,” had
244 responses. The majority (60.2%) answered “Strongly agree” or “Agree,” while 18.0% answered “Strongly disagree” or “Disagree.
The fourth statement, “Suggested solutions to my concerns about side effects,” had 244 responses. 43.9% answered “Strongly agree” or “Agree,” while 18.9% answered “Strongly disagree” or “Disagree.”
The fifth statement, “Implemented effective solutions,” had 243 responses. 43.6% of respondents answered “Strongly agree” or “Agree,” while 16.0% of respondents answered
“Strongly disagree” or “Disagree.”
The sixth statement, “Knew enough about birth control to help me,” had 243 responses.
The majority (74.5%) of respondents answered “Strongly agree” or “Agree,” while 8.2% of respondents answered “Strongly disagree” or “Disagree.”
The seventh statement, “Sufficiently involved me in the process of choosing the birth control that worked best for me,” had 244 responses. 38.5% of respondents answered “Strongly agree” or “Agree,” and another 38.5% answered “Strongly disagree” or “Disagree.”
Figure 17a. Figure 17b. Figure 17c.
Figure 17d. Figure 17e. Figure 17f. Figure 17g. Figures 17a-g. Responses to questions about respondents’ experiences with healthcare
professionals.
Ranking Brands by Side Effects Experienced
The survey data collected allows for a ranking of brands based on side effects reported per brand. A table of all side effects reported per brand can be found in Appendix B. In the following section, there is a table of the “Top 20” brands of OC, meaning the 20 brands with the fewest side effects reported. There is also a table of the “Bottom 20” brands of OC, meaning the
20 brands with the most side effects reported. Also included are “Adjusted Top 20” and
“Adjusted Bottom 20” tables.
The adjusted tables are necessary because of a limitation of the survey data; there were different quantities of respondents reporting on each brand. For example, Junel® Fe ranks lowest on the unadjusted list because there were 53 counts of side effect reports with Junel® Fe. Part of the reason for this high count of side effect reports is because 26 respondents reported using
Junel® Fe, which is one of the highest counts of respondents per brand throughout the survey data. With a higher sample size of respondents using Junel® Fe, it follows that Junel® Fe may have a higher total count of side effect reports than a brand that only 1 or 2 survey respondents reported using.
The adjusted rankings were made using the average number of side effect reports per respondent. All side effect reports within a brand were added together, then divided by the number of respondents who reported using that brand. For example, the brand Enpresse® had 1 report of bleeding and 1 report of mood swings, adding up to a total of 2 side effect reports. A total of 2 respondents reported using Enpresse®, so as a result Enpresse® has an average of 1 side effect report per respondent. To encourage data transparency, the total number of respondents per brand has been included in all ranking tables.
Top 20
Ranking (1= fewest Brand Total Total Side Effect side effect reports) Respondents Reports
1 Aranelle® 1 0
1 Jolivette® 1 0
1 Lutera® 1 0
1 Necon® 1/50 1 0
1 Ortho Tri-Cyclen® Lo 2 0
1 Zarah® 1 0
2 Microgestin® 1 1
2 Necon® 0.5/35 1 1
2 Ortho-Cyclen® 1 1
3 Enpresse® 2 2
3 Lo/Ovral® 2 2
3 Mircette® 1 2 3 Previfem® [DSC] 1 2
3 Seasonale® 1 2
3 Seasonique® 2 2
3 Zovia® 1 2
4 Azurette® 2 3
4 Kelnor® 1 3
4 Lessina® 1 3
4 Levora® 1 3 Table 1. Top 20 brands based on fewest side effect reports per brand.
Bottom 20
Ranking (1= most side Brand Total Respondents Total Side Effect Reports effect reports)
1 Junel® Fe 26 53
2 Sprintec® 27 50
3 Loestrin® Fe 22 49
4 Kariva® 10 32
4 Tri-Previfem® 13 32 [DSC]
5 Junel® 13 30
6 Norethidrone® 11 28
7 Tri-Sprintec® 13 25
8 Apri® 14 24
9 Loestrin® 7 23 10 Cryselle® 8 18
11 Aviane® 7 16
12 Brevicon® 3 15
13 TriNessa® 3 13
14 Sronyx® 7 12
15 Beyaz® 2 11
15 Loryna® 3 11
16 Nortrel® 5 10
16 Ortho 5 10 Tri-Cyclen®
16 Yaz® 6 10 Table 2. Bottom 20 brands based on most side effect reports per brand.
Adjusted Top 20
Ranking (1= lowest Brand Total Average Side Effect Reports per average side effect Respondents Respondent reports per respondent)
1 Aranelle® 1 0
1 Jolivette® 1 0
1 Lutera® 1 0
1 Necon® 1/50 1 0
1 Ortho 2 0 Tri-Cyclen® Lo
1 Zarah® 1 0
2 Enpresse® 2 1 2 Lo/Ovral® 2 1
2 Microgestin® 1 1
2 Necon® 0.5/35 1 1
2 Ortho-Cyclen® 1 1
2 Seasonique® 2 1
3 Microgestin® Fe 5 1.4
4 Azurette® 2 1.5
5 Gianvi® 5 1.6
6 Yaz® 6 1.67
7 Apri® 14 1.71
7 Sronyx® 7 1.71
8 Sprintec® 27 1.85
9 Tri-Sprintec® 13 1.92 Table 3. Adjusted Top 20 brands based on lowest average side effect reports per respondent.
Adjusted Bottom 20
Ranking (1= Brand Total Average Side Effect Reports per highest average Respondents Respondent side effect reports per respondent)
1 Quasense® 1 6
2 Beyaz® 2 5.5
3 Brevicon® 3 5
3 Leena® 1 5
4 TriNessa® 3 4.33
5 MonoNessa® 1 4 6 Loryna® 3 3.67
7 Camila® 3 3.33
8 Loestrin® 7 3.29
9 Kariva® 10 3.2
10 Kelnor® 1 3
10 Lessina® 1 3
10 Levora® 1 3
11 Norethidrone® 11 2.55
12 Camrese® 4 2.5
12 Errin® 2 2.5
13 Tri-Previfem® 13 2.46 [DSC]
14 Junel® 13 2.31
15 Aviane® 7 2.29
16 Yasmin® 4 2.25 Table 4. Adjusted Bottom 20 brands based on highest average side effects per respondent.
The Side Effects Troubleshooting Tool (SETT)
The ultimate development of this project was the creation of the Side Effects
Troubleshooting Tool (SETT). SETT was created by combining data on (1) what brands of OC respondents tried, (2) what side effects they experienced with those brands, (3) if respondents switched brands, what brands they switched to, and (4) if that switch was effective in removing the side effects they experienced with the previous brand. SETT is a Microsoft Excel workbook that a viewer can click through to view different Excel sheets displaying side effects experienced with each brand and to what extent switches to different brands were effective. A walkthrough of an example use of SETT follows. After opening SETT, the viewer sees the home page and is instructed to select a brand. Any brand in blue text has side effect data that can be viewed by clicking on the associated blue text.
Figure 18. Excerpt from SETT home page.
In this example, the viewer then selects Junel® Fe. The viewer is then taken to the Junel® Fe main page. On the main page, the viewer can see the brand name, the total number of survey respondents who reported using Junel® Fe, a list of side effects, and the number of respondents who reported experiencing each side effect. If there is no number in the “Report count:” column, that means that no respondents reported experiencing the associated side effect. Any side effect in blue text has data about switching brands that can be viewed by clicking on the associated blue text. There is also a “HOME” button that the viewer can press to return to the SETT home page.
Figure 19. Junel® Fe main page.
If the viewer then clicks on “Irritability,” they will be taken to the Junel® Fe Irritability side effect page. On this page, the viewer can see the brand name and can click on the brand name to return to the Junel® Fe main page. The viewer can also see the side effect in question. “Brand switched to:” indicates brands that respondents switched to directly after using Junel® Fe.
“Effective solution:” contains the respondent’s answer to if this particular brand switch stopped the respondent from experiencing the irritability side effect. “Count:” means the number of respondents who switched to the brand in that row and experienced the outcome also in that row.
Figure 20. Junel® Fe Irritability side effect page.
The viewer can then click on any of the brands switched to that are in blue text to be taken to the main pages of those brands and look at their side effects. The viewer can also click on “Junel Fe” and be taken back to the Junel® Fe main page, where they can look at the other side effects or return to the SETT main page and start the process with another brand.
All brands in SETT follow the home page to brand main page to side effect page pattern, with varying amounts of data available for each brand. Throughout SETT, any underlined blue text can be clicked to take the viewer to the associated page. Any text that is not underlined blue text will not lead the viewer to any further pages.
Discussion
The purpose of this project was to gain information on and encourage further research into OCs and their side effects. Through a thorough review on the literature available on the topic, a survey-based study with over 300 participants, and the creation of SETT, this project takes an initial step toward making a safer and overall more positive experience for those who use OCs. High Occurrence of Side Effects and Discontinuation
A significant takeaway from the survey results is the high occurrence of side effects. Out of the 281 respondents who had tried at least one brand of OC, 240 respondents (85.4%) experienced at least one side effect with at least one of the brands they tried, which is a higher percentage than any similar statistic in the literature referenced in this project’s literature review.
For a pharmaceutical product that has existed for more than sixty years and is used by 12.6% of women in the United States alone, this high occurrence of side effects should be unacceptable
(Daniels & Abma, 2018; Liao & Dollin, 2012). Increased research into how to address these side effects is absolutely necessary.
Part of the reason why addressing these side effects is so necessary is that, both according to these survey results and in accordance with much of the literature, experiencing side effects is the most common reason for discontinuation. If the medical community wants to increase continuation of OCs, it follows that the first thing to address should be these side effects.
Why Focus on Brands?
This project places an emphasis on differences between brands of OCs because, as seen in this project’s results, a person’s experience with OCs can change from brand to brand. Also, a switch in OC brand is relatively easy for a patient to request and for a prescriber to prescribe when compared with the large-scale time and effort needed to conduct and apply the medical research necessary to address the side effects of any given OC brand. Researching differences between brands and applying this research by counseling brand switches for patients is a short-term, band-aid solution to improving patients’ experience with OCs. The long-term solution proposed in this paper is to conduct and apply the medical research needed to greatly decrease, and ideally eliminate, the side effects associated with any brand of OC before patients are prescribed that product.
Key differences between brands that may contribute to a patient’s different experiences include varying doses of estrogen compound, different types of progestin compound, monophasic versus multiphasic dosages, and length of active/placebo pill regimens (Hall &
Trussell, 2012; Stegeman et al., 2013). In short, there can be many differences in product formulation from one brand to another.
Also relevant within this topic are differences between a brand-name OC and its associated generic brands. According to Food and Drug Administration (FDA) guidelines passed in 1984, the generic version of a brand-name product must be both therapeutically equivalent, meaning identical in active ingredients and their dosage, and bioequivalent, meaning showing no significant difference in absorption in clinical trials (Sober & Schreiber, 2011). According to a
2011 editorial in Contraception, “there is no strong evidence” that generics should not be considered interchangeable with the associated brand-name products (Sober & Schreiber, 2011).
Essentially, if a generic is available for a brand-name OC, that means the FDA says that those two products are effectively the same. However, “therapeutically equivalent drugs may differ in their inert ingredients, packaging, color, shape, flavor, expiration time and labeling” (Sober &
Schreiber, 2011). These possible small differences between brand-name and generic have been shown to cause no difference in rates of effective pregnancy prevention (Sober & Schreiber,
2011). Outside of pregnancy prevention, on the other hand, both patients and clinicians have reported problems anecdotally after switching between brand-name and generic OCs (Sober &
Schreiber, 2011). While effective pregnancy prevention is absolutely necessary in an OC, it is not the only factor in a patient’s OC experience. Small differences between brand-name and generic OCs, particularly inert ingredients, are worth further research for the purpose of gaining information about and addressing side effects.
This project provides an example of such research, as data was collected on both generic and brand-name OCs. One example of a generic/brand-name pair included in the data is the pair of Yaz® and Loryna®. Loryna® is a generic form of Yaz® (Bliss, 2017). While Yaz® is in the
Adjusted Top 20 (Table 3) with an average of 1.67 side effects per respondent, Loryna® is in the
Adjusted Bottom 20 (Table 4) with an average of 3.67 side effects per respondent. Further research is needed to determine differences in experienced side effects between brand-name OCs and their generic near-equivalents.
Overall, this project places a focus on brand-to-brand differences because differences between brands of OCs, and even potentially differences between OC brands and their generics, may influence a patient’s experience with side effects. As the purpose of this project is to encourage increased research into the side effects of OCs in order to address these side effects, brand-to-brand differences are a fitting focus.
Purpose of SETT
The Side Effects Troubleshooting Tool (SETT) serves multiple purposes. The first is to serve as a resource for people considering using OCs or people who are using one brand of OC and considering switching to another brand due to side effects. The second purpose is to serve as a blueprint for future research on the topic. The third purpose, once additional similar but larger-scale research is conducted, is to serve as a reference for healthcare providers when they are counseling a patient on what brand to switch to in order to address the patient’s side effects. Resource for Patients
Throughout the process of starting and using OCs, patients generally wish to be fully informed on the product they may be using. Patients usually have the opportunity to gain information from their healthcare provider, but that provider may not have or give all the information that the patient desires. In this study, most respondents (54.7%) responded that they
“Disagree” or “Strongly disagree” with the statement that their healthcare provider offered them enough information on the different types of OCs (Figure 17b). SETT is a resource for these patients that are seeking more information.
SETT received its name from this aspect of its purpose, as a tool for patients to troubleshoot the side effects they may be experiencing with their OCs. If SETT is shared in a way that the general public has access to it, a patient struggling with side effects of a particular
OC can ask their healthcare provider for their opinion on switching to a brand that was reported to be an effective solution for a respondent involved in SETT. If this switch is approved and made by the healthcare provider and the patient no longer struggles with that side effect, SETT will have served this aspect of its purpose.
Blueprint for Research
As stated throughout this paper, more research on OCs and their side effects is absolutely necessary. While the results of this survey are valuable on their own, replicated research with larger sample sizes can provide the data necessary to draw further developed conclusions about
OC side effects. SETT, and the survey behind it, is intended to serve as a blueprint for larger-scale research. Ideally, researchers with access to the time, resources, and populations necessary to conduct a larger-scale replication of this study will create their own versions of SETT that can be combined into a well-researched tool that can help patients, providers, and the medical community as a whole.
Reference for Healthcare Providers
Once additional research is conducted and a further developed version of SETT is available, healthcare providers may be able to use SETT to help counsel patients through the OC process. Similar to how patients can use SETT as a resource to consult their provider about, providers can reference SETT when a patient reports side effects with a certain OC brand. If the provider involves SETT in their decision to prescribe another OC brand to the patient, SETT will have served this aspect of its purpose.
Conclusion
This paper recognizes the lack of research into oral contraceptives and their side effects.
Throughout the project process, the intent of this project has been to address this problem by encouraging research into OCs. The main reason this project promotes research into OCs is specifically to address side effects. OCs have already been studied and proven to prevent pregnancy, as well as help with some other medical needs. While these purposes could warrant some additional research as well, side effects have continuously been overlooked as an OC research focus and need attention from the medical community. Just because the people who use
OCs receive the benefits of OCs does not mean they should be expected to deal with the drawbacks of a wide range of side effects that are difficult to predict and manage. Increased research into side effects is needed to create a positive OC experience for everyone who uses them.
This project made a step forward in achieving this goal not only by encouraging research, but also by conducting and analyzing original research. With the basis of a thorough literature review, a survey was designed to ask people who used OCs about their experiences. Data was collected from over 300 participants through use of this survey. By analyzing this data, key findings emerged, most significantly that 85.4% of respondents who had tried at least one brand of OC had experienced at least one side effect. This finding, coupled with the finding that experience of side effects was the most common reason for OC discontinuation, further bring to light the need to address this problem through increased medical research. Also as part of this project, OC brands were ranked both by number of side effect reports and by an adjusted ranking of average side effect reports per respondent. As an additional element of this project, based on respondents’ experiences with side effects and switching brands, the Side Effects
Troubleshooting Tool (SETT) was created as a resource for patients, blueprint for future research, and a reference for healthcare providers.
A separate interesting finding from the survey data was that for every “Reason(s) for using [brand]” question, the top reason for using was relief from menstruation symptoms. With
“birth control” being a common colloquially used term for OCs, these survey results stand out.
While pregnancy prevention remained the second most common reason for use throughout the survey results, it seems that “hormone control” or another such term may be a more appropriate way to refer to OCs in some cases. Even the term “oral contraceptives” focuses on the pregnancy prevention aspect of the pharmaceutical product. By finding a new term for OCs that does not focus on the pregnancy prevention aspect, the medical and other involved communities can portray a more accurate picture of the product. This adjustment in terminology may even help shift the sexual stigma sometimes unjustly associated with OCs that has historically, and arguably into the present, hampered research into OCs and their side effects. This idea and its consequences are worth further research. Oral contraceptives are a necessary and beneficial resource for millions of people worldwide. These people who use and depend on OCs to fit their medical needs deserve a positive experience with OCs, unimpeded by harmful side effects. Though much advancement has been made during the existence of OCs, more research must be conducted to further inform the medical community about these side effects and how to address them. By conducting initial research on people’s experiences with OC side effects and encouraging further research, this project makes steps toward the goal of addressing, and ideally eliminating, OC side effects. This project will hopefully direct the medical community and its patients toward a future of an OC experience that is completely stress-free, simple, and safe for all. References
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What are the different types of contraception? (2017). Retrieved from
https://www.nichd.nih.gov/health/topics/contraception/conditioninfo/types Appendix A
Qualtrics Survey (Converted to and copied from Microsoft Word)
Improving Oral Contraceptives [FINAL]
Start of Block: Intro
Q21 Thank you for taking the time to answer these questions. The estimated time to take this survey is approximately 5 minutes.
This survey is part of a Major Qualifying Project at Worcester Polytechnic Institute. The project's goal is to improve oral contraceptives through policies that encourage increased medical research into their side effects. In this survey, you will have the opportunity to share your experiences with oral contraceptives, including your experiences with side effects and experiences with your doctor(s)/ prescriber(s)/ healthcare professional(s). Your answers will be used to inform the project and potentially offer additional perspectives to people seeking information about oral contraceptives.
Your responses are anonymous and voluntary, and you can omit answers to any question you do not feel comfortable answering.
Would you like to proceed?
o Yes (1)
o No (2)
Skip To: End of Survey If Thank you for taking the time to answer these questions. The estimated time to take this survey i... = No
End of Block: Intro
Start of Block: Demographics
Q1 What is your age?
______
Q22 You identify as a:
o Woman (1) o Nonbinary person (2)
o Man (3)
o Other: (4) ______
Q27 Are you currently living in the United States?
o Yes (1)
o No (2)
Skip To: End of Survey If Are you currently living in the United States? = No
Q2 In what state are you currently living?
▼ Alabama (1) ... I do not live in the United States (51)
Skip To: End of Survey If In what state are you currently living? = I do not live in the United States
End of Block: Demographics
Start of Block: Have you...
Q3 Have you ever used an oral contraceptive, also known as a birth control pill?
o Yes (1)
o No (2)
Skip To: End of Survey If Have you ever used an oral contraceptive, also known as a birth control pill? = No
End of Block: Have you...
Start of Block: Contraceptives
Q4 What brand of oral contraceptive did you try ${lm://Field/1}? (${lm://Field/2}/5)
▼ Does not apply (I have not tried any additional brands) (3154) ... Other (3246) Display This Question:
If Loop all: What brand of oral contraceptive did you try ${lm://Field/1}? (${lm://Field/2}/5) = Other
Q23 Please describe "other":
______
Page Break
Display This Question:
If Loop all: What brand of oral contraceptive did you try ${lm://Field/1}? (${lm://Field/2}/5) != Does not apply (I have not tried any additional brands)
Q11 At what age did you begin using ${Q4/ChoiceGroup/SelectedChoices}?
______
Display This Question:
If Loop all: What brand of oral contraceptive did you try ${lm://Field/1}? (${lm://Field/2}/5) != Does not apply (I have not tried any additional brands)
Q6 Reason(s) for using ${Q4/ChoiceGroup/SelectedChoices}:
▢ Prevent pregnancy (1)
▢ Relief from menstruation symptoms (ex: heavy periods, painful periods, irregular bleeding) (2)
▢ Treat acne (3) ▢ Treat hirsutism (excessive face/body hair growth) (4)
▢ Treat endometriosis (5)
▢ Reduce cancer risk (6)
▢ Other (please describe): (7) ______
Display This Question:
If Loop all: What brand of oral contraceptive did you try ${lm://Field/1}? (${lm://Field/2}/5) != Does not apply (I have not tried any additional brands)
Q7 Side effect(s) experienced while using ${Q4/ChoiceGroup/SelectedChoices}:
▢ Bleeding (1)
▢ Nausea (2)
▢ Fluid retention (weight gain) (3)
▢ Mood swings (4)
▢ Irritability (5)
▢ Depressive symptoms (6)
▢ Eating disorder (7)
▢ Ovarian cysts (8)
▢ Venous Thromboembolic Disease (VTE) (9)
▢ Arterial Thromboembolism (10) ▢ Breast cancer (11)
▢ Cervical cancer (12)
▢ Other cancer (please describe): (13) ______
▢ Other (please describe): (14) ______
Display This Question:
If Loop all: What brand of oral contraceptive did you try ${lm://Field/1}? (${lm://Field/2}/5) != Does not apply (I have not tried any additional brands)
Q9 How many months have you used/ did you use ${Q4/ChoiceGroup/SelectedChoices} for?
▼ 1 (1) ... 12+ (12)
Display This Question:
If Loop all: What brand of oral contraceptive did you try ${lm://Field/1}? (${lm://Field/2}/5) != Does not apply (I have not tried any additional brands)
Q13 Are you currently using ${Q4/ChoiceGroup/SelectedChoices}?
o Yes (1)
o No (2)
Page Break
Display This Question:
If Loop current: Are you currently using ${q://QID4/ChoiceGroup/SelectedChoices}? = No
Q10 Reason(s) for discontinuation: ▢ Experienced side effect(s) (1)
▢ Feared side effect(s) not experienced (2)
▢ Logistics (ex: cost, remembering to take pill, ability to refill pills) (3)
▢ Fertility (ex: not sexually active, pregnant, desire to become pregnant) (4)
▢ Partner-related (ex: partner's attitude toward pill) (5)
▢ Other (please describe): (6) ______
Display This Question:
If Loop current: Are you currently using ${q://QID4/ChoiceGroup/SelectedChoices}? = No
Q12 Did you switch to a different brand of oral contraceptive?
o Yes (1)
o No (2)
Page Break
Display This Question:
If Loop current: Did you switch to a different brand of oral contraceptive? = No
Q14 What form of contraception do you use now?
▢ Long-Acting Reversible Contraception (LARC) (ex: IUD, Implants) (1)
▢ Hormonal Methods (ex: Injectable birth control, Contraceptive patch, Vaginal ring) (2)
▢ Barrier Methods (ex: Condoms, Contraceptive sponges, Spermicides, Diaphragms, Cervical caps) (3) ▢ Emergency Contraception (4)
▢ Sterilization (5)
▢ No contraception (6)
▢ Other (please describe): (7) ______
Page Break
Display This Question:
If Loop current: Did you switch to a different brand of oral contraceptive? = Yes
Q15 Did the next brand you tried remove the side effects you experienced with the previous brand?
o Yes (1)
o Yes, but I experienced new side effects (2)
o No (3)
o I did not experience side effects with the previous brand (4)
End of Block: Contraceptives
Start of Block: Block 9
Q25 Have you tried 6 or more brands of oral contraceptive?
o Yes (5)
o No (6)
Display This Question: If Have you tried 6 or more brands of oral contraceptive? = Yes
Q26 Please list the additional brands you have tried, in order from sixth to last:
______
End of Block: Block 9
Start of Block: Doctor matrix
Q17 To what extent do you agree with the following statements: "My doctor(s)/ prescriber(s)/ healthcare professional(s)..."
Strongly Agree Neither Disagree Strongly Does not agree (1) (2) agree nor (4) disagree apply (6) disagree (5) (3)
Offered me enough o o o o o o information on the different types of birth control (1)
Offered me enough o o o o o o information on the different types of oral contraceptives (2)
Listened to and o o o o o o understood my concerns about side effects (3) Suggested solutions to o o o o o o my concerns about side effects (4)
Implemented effective o o o o o o solutions (5)
Knew enough about birth o o o o o o control to help me (6)
Sufficiently involved me o o o o o o in the process of choosing the birth control that worked best for me (7)
End of Block: Doctor matrix
Start of Block: Final comments
Q18 Do you have any additional comments about your experiences with side effects?
______
______
______
______
______Q19 Do you have any additional comments about your experiences with your doctor(s)/ prescriber(s)/ healthcare professional(s)?
______
______
______
______
______
End of Block: Final comments Appendix B
Side Effects Chart