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Existing and Emerging Shorter-Acting Nondaily Hormonal Contraceptives supplement to March 2013 Available at obgmanagement.com Existing and Emerging Shorter-Acting Nondaily Hormonal Contraceptives Andrew M. Kaunitz, MD professor and Associate Chair, Department of obstetrics and Gynecology, university of Florida College of medicine, Jacksonville Anita Nelson, MD professor, Department of obstetrics and Gynecology, David Geffen school of medicine, university of California, los Angeles Sujatha Prabhakaran, MD, MPH Vice president, medical Affairs, planned parenthood of southwest and Central Florida, sarasota this supplement is sponsored by Agile® therapeutics Copyright © 2013 Frontline medical Communications, Inc. supplement to this supplement is sponsored by Agile® therapeutics March 2013 Existing and Emerging Shorter-Acting Nondaily Hormonal Contraceptives Andrew M. Kaunitz, MD; Anita Nelson, MD; and Sujatha Prabhakaran, MD, MPH ver half of all pregnancies in the united states intrauterine devices (IuDs) and contraceptive implants, (us) are unintended; an estimated 42% of these should be first-line choices for preventing unintended unintended pregnancies result in induced abor- pregnancy.7 these methods can be used by most o 1-3 tion or miscarriage. unintended pregnancies have women, including adolescents, nulliparous women, and profound adverse effects not only on maternal health, women with contraindications for estrogen use. lARCs but also on infant and child health outcomes, including provide advantages not offered by shorter-acting meth- increased risk of low birth-weight, neonatal mortality, ods, as they are not user-dependent, do not require and infant developmental delay.4 to decrease unin- daily/frequent adherence, have high rates of satisfac- tended pregnancy, clinicians must collaborate with tion and continuation, and provide top-tier effective- their patients to optimize correct and consistent con- ness during typical use.3,6,8 A recent, large, prospective traceptive use. offering the full range of contraceptive cohort study found that participants using shorter- options and providing counseling to help a woman acting methods such as oCs, the transdermal patch, or a choose a method that meets her individual needs is vaginal ring, had a risk of contraceptive failure that was critical to optimal contraceptive success and family 20 times higher than women who used lARCs.3 planning. Advances in contraceptive technology offer Between daily pills and the long-acting meth- women today many options, from shorter-acting daily ods are intermediate methods, such as depot- and nondaily options to longer-acting contracep- medroxyprogesterone acetate (DmpA). Both intramus- tive methods. while oral contraceptives (oCs), which cular and subcutaneous injections are available in the require daily use to prevent pregnancy, are still the us. the failure rate with typical use is 6.8%.3 DmpA most popular method in the us, long-acting reversible for subcutaneous injection (DmpA-sC) may facilitate contraceptives (lARCs) have gained favor, as they pro- (off-label) self-administration,9,10 and like DmpA, is vide user convenience and satisfaction and the lowest a highly effective contraceptive when used consis- probability of method failure.3,5,6 tently.3 Both injectable formulations are required every 3 months and are attractive to women who find daily dosing challenging or inconvenient.11 Recent advances in contraceptive technology Despite the advantages of lARCs and DmpA, utiliza- tion may be diminished by lack of access due to cost , offer women today a wide range of contra- limited access to trained healthcare providers,12 or ceptive choices, from shorter-acting daily and nondaily options to longer-acting methods Disclosures dr. Kaunitz reports that his institution receives research funding from Agile, Bayer, and teva, and that he is a consultant for Agile, Bayer, and merck. LoNg-actiNg REversible dr. Nelson reports receiving grants/research funding from Bayer, merck, CoNtraceptivE MEtHodS pfizer, andt eva; receiving speakers bureau honoraria from Bayer, merck, and teva; and being a consultant/advisory board member for Agile, Bayer, According to the recent American College of obstetri- Ferring, merck, teva, and watson. cians and Gynecologists guideline, lARCs, including dr. prabhakaran reports that she has no financial relationships to disclose. Available At www.obgmAnagement.Com supplement to oBG management | march 2013 S1 shoRteR-actInG nondaily hoRmonAl Contraceptives patient preferences.4,7,12 problems with early IuDs and tion methods), including a lower incidence of ovarian, misperceptions regarding safety and liability issues endometrial, and colorectal carcinoma and benign with IuDs may discourage use of these contracep- breast disease and reduction of menstrual irregularity, tives.13 Concerns regarding menstrual changes and dysmenorrhea, ectopic pregnancy, and gonococcal- other side effects also may result in discontinuation of related hospitalizations for pelvic inflammatory dis- lARCs and DmpA or curtail their use.7,12 ease, with no increase in breast cancer.15,16 several some women may prefer more control over their CoCs are approved for the treatment of acne15,17; one contraceptive method and favor reversible, user- formulation is approved for the treatment of premen- dependent contraception, such as barrier methods, strual dysphoric disorder,18 while another is approved that may not require the intervention of a healthcare for treatment of heavy menstrual bleeding.19 provider. women who are considering child bearing progestin-only oral contraceptives (pops, or mini- in the near future may be less amenable to lARCs or pills) can be used virtually by every woman20 but, unlike DmpA and favor shorter-acting nondaily or daily hor- combined hormonal methods, do not provide more monal options. predictable bleeding. Bleeding episodes with pops are also usually more frequent, as well as longer or shorter, SHoRt-actiNg Hormonal but pop users have fewer days of spotting than with CoNtraceptivE MEtHodS CoCs.21 Failure rates in typical use of pops are the same oral Contraceptives as with CoCs but failure rates for pops may be higher oral contraceptives are the most frequently prescribed than CoCs if the CoCs are taken correctly and consis- form of contraception in the us and are used by over tently.22 pops are more susceptible to interaction with 12 million American women, representing 38% of drugs that increase hepatic cytochrome p450 activity. reproductive-age women.5,8 when oral contraception was developed more than 50 years ago, it provided Safety/Side Effects/Efficacy Challenges women for the first time a safe, effective, and nonin- the association of CoCs with venous thromboembo- trusive way to avoid pregnancy. since its develop- lism (Vte) is well known and prompted the substantial ment, women in the us have equated contraception reduction of estrogen found in current CoCs as noted with “the pill.” there has been a steady evolution from earlier.23 Doses of ee above 35 mcg have been shown the first formulations, combination oCs (CoCs) that to have higher Vte risk, but the increased safety of combined high estrogen and progestin doses in 21/7 sub–35-mcg formulations is not clearly documented.24 packaging.14 the dosage of ethinyl estradiol (ee) has whether or not the type of progestin also contributes decreased to as low as 10 mcg; one new pill uses estradiol val- erate as its estrogen rather figure 1 Likelihood of developing a blood clot than ee. new progestins have been introduced with dif- ferent metabolic effects and different noncontraceptive Nonpregnant Ranges from benefits. new formulations Non–COC user 1 to 5 with monthly multiphasic combinations of estrogen and Ranges from COC user progestin and formulations 3 to 9 that reduce the number of Ranges from scheduled bleeding episodes Pregnancya offer women new approaches 5 to 20 and allow for more individual- Postpartum Ranges from ization of pill selection. other (12 weeks only) 40 to 65 ingredients, such as iron and folate, have been added to 0 10 20 30 40 50 60 70 provide direct health benefits. Number of Women with a Blood Clot out of 10,000 Woman-Years A large body of evidence demonstrates the noncon- CoC, combination oral contraceptives. traceptive health benefits of CoC use (presumed to also a Pregnancy data are based on actual duration of pregnancy in relevant studies; based on a model assumption that be relevant to transdermal pregnancy duration is 9 months, the rate would be 7 to 27 per 10,000.28 and vaginal ring combina- S2 march 2013 | supplement to oBG management to Vte risk remains controversial and uncertain, with studies employing varying methodologies reaching short-acting nondaily options, such as the 23,25-27 different conclusions. patient selection remains vaginal ring and transdermal patch, offer the important because of the significant contributions of age, obesity, smoking, and sedentary lifestyles to Vte convenience of less frequent dosing than oCs risk. however, a more important issue is the profound with comparable contraceptive efficacy increase in Vte risk with pregnancy and following childbirth (Figure 1).28 As the prevalence of obesity among women in the us continues to increase, attention has also focused on vaginal Ring the efficacy of shorter-acting contraceptives in obese Vaginal ring contraception provides women with women.29 Incomplete ovarian suppression due to effective birth control with once-a-month adminis- lower serum levels of both estrogens and progestins tration without the need for daily intervention.36
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