The Progestogen Only Pill
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35 Cyproterone Acetate and Ethinyl Estradiol Tablets 2 Mg/0
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrCYESTRA®-35 cyproterone acetate and ethinyl estradiol tablets 2 mg/0.035 mg THERAPEUTIC CLASSIFICATION Acne Therapy Paladin Labs Inc. Date of Preparation: 100 Alexis Nihon Blvd, Suite 600 January 17, 2019 St-Laurent, Quebec H4M 2P2 Version: 6.0 Control # 223341 _____________________________________________________________________________________________ CYESTRA-35 Product Monograph Page 1 of 48 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................................. 3 INDICATION AND CLINICAL USE ..................................................................................................... 3 CONTRAINDICATIONS ........................................................................................................................ 3 WARNINGS AND PRECAUTIONS ....................................................................................................... 4 ADVERSE REACTIONS ....................................................................................................................... 13 DRUG INTERACTIONS ....................................................................................................................... 16 DOSAGE AND ADMINISTRATION ................................................................................................ 20 OVERDOSAGE .................................................................................................................................... -
Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals
Journal of Clinical Medicine Review Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals Carlotta Cocchetti 1, Jiska Ristori 1, Alessia Romani 1, Mario Maggi 2 and Alessandra Daphne Fisher 1,* 1 Andrology, Women’s Endocrinology and Gender Incongruence Unit, Florence University Hospital, 50139 Florence, Italy; [email protected] (C.C); jiska.ristori@unifi.it (J.R.); [email protected] (A.R.) 2 Department of Experimental, Clinical and Biomedical Sciences, Careggi University Hospital, 50139 Florence, Italy; [email protected]fi.it * Correspondence: fi[email protected] Received: 16 April 2020; Accepted: 18 May 2020; Published: 26 May 2020 Abstract: Introduction: To date no standardized hormonal treatment protocols for non-binary transgender individuals have been described in the literature and there is a lack of data regarding their efficacy and safety. Objectives: To suggest possible treatment strategies for non-binary transgender individuals with non-standardized requests and to emphasize the importance of a personalized clinical approach. Methods: A narrative review of pertinent literature on gender-affirming hormonal treatment in transgender persons was performed using PubMed. Results: New hormonal treatment regimens outside those reported in current guidelines should be considered for non-binary transgender individuals, in order to improve psychological well-being and quality of life. In the present review we suggested the use of hormonal and non-hormonal compounds, which—based on their mechanism of action—could be used in these cases depending on clients’ requests. Conclusion: Requests for an individualized hormonal treatment in non-binary transgender individuals represent a future challenge for professionals managing transgender health care. For each case, clinicians should balance the benefits and risks of a personalized non-standardized treatment, actively involving the person in decisions regarding hormonal treatment. -
WHO Statement on Progestogen-Only Implants
WHO statement on Progestogen-only implants Key facts Progestogen-only implants consist of hormone-filled capsules or rods that are inserted under the skin in a woman’s upper arm The purpose of this Statement is to reiterate and Life-Saving Commodities for Women and Children clarify the existing (current) WHO position based on endorsed contraceptive implants as one of its 13 Life- published guidance that is still valid. WHO monitors Saving Commodities. the evidence in this field closely and will update Primary mechanisms of action of the implants include its guidance as and when new evidence becomes thickening cervical mucus (making it difficult for available. sperm to penetrate) and preventing ovulation in KEY FACTS ABOUT PROGESTOGEN-ONLY IMPLANTS about half of menstrual cycles. Long-acting reversible contraceptives, including USE OF PROGESTOGEN-ONLY IMPLANTS BY intrauterine devices and implants are the most WOMEN LIVING WITH HIV effective methods of reversible contraception. These There have been concerns from recent publications methods have multiple advantages over other regarding the effectiveness of progestogen-only reversible methods. Most importantly, once in place, implants among women living with HIV and on they do not require daily or monthly dosing and their some antiretroviral drugs.1 However, compared with duration of contraceptive action ranges from 3 to 5 other hormonal methods, no significant differences years. in pregnancy rates have been observed with Progestogen-only implants consist of hormone-filled progestogen-only implants.2 capsules or rods that are inserted under the skin of a woman’s upper arm. Current systems consist of one or two rods. -
SLINDA® (DROSPIRENONE 4 Mg) TABLETS
SLINDA® (DROSPIRENONE 4 mg) TABLETS AUSTRALIAN PRODUCT INFORMATION AUSTRALIAN PRODUCT 4.2 Dose And Method Of INFORMATION Administration SLINDA® (DROSPIRENONE) TABLETS Dose How to take SLINDA 1. NAME OF THE MEDICINE One tablet is to be taken daily for 28 Drospirenone consecutive days; one white active tablet daily during the first 24 days and one green inactive tablet 2. QUALITATIVE daily during the 4 following days. Tablets must be taken every day, at about AND QUANTITATIVE the same time of the day, so that the COMPOSITION interval between two tablets is always 24 hours. Tablets should be taken in White active film-coated tablets: the order shown on the blister. Stickers Each tablet contains 4 mg of marked with the 7 days of the week are drospirenone. provided. The patient should choose the sticker that starts with the day they Green placebo film-coated tablets: begin taking the tablets and stick it on The tablet does not contain active the blister. substances. The first tablet of the treatment should Excipient(s) with known effect: be taken on the first day of menstrual Each white active film-coated tablet bleeding. Thereafter tablet taking contains 17.5 mg of lactose. is continuous. A subsequent pack is started immediately after finishing the Each green placebo film-coated tablet previous pack, without a break in daily contains 55.5 mg of lactose monohydrate. tablet intake. For the full list of excipients, see section How to start SLINDA 6.1 List of Excipients. No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the 3. -
Desogestrel-Only Pill (Cerazette)
J Fam Plann Reprod Health Care: first published as 10.1783/147118903101197593 on 1 July 2003. Downloaded from Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit A unit funded by the FFPRHC and supported by the University of Aberdeen and SPCERH to provide guidance on evidence-based practice New Product Review (April 2003) Desogestrel-only Pill (Cerazette) Journal of Family Planning and Reproductive Health Care 2003; 29(3): 162–164 Evidence from a randomised trial has shown that a 75 mg (microgrammes) desogestrel pill inhibits ovulation in 97% of cycles. Thus, on theoretical grounds, we would expect the desogestrel pill to be more effective than existing progestogen- only pills (POPs). However, Pearl indices from clinical trials comparing it to a levonorgestrel POP were not significantly different. Therefore an evidence-based recommendation cannot be made that the desogestrel pill is different from other POPs in terms of efficacy, nor that it is similar to combined oral contraception (COC) in this respect. An evidence-based recommendation can be made that the desogestrel-only pill is similar to other POPs in terms of side effects and acceptability. The desogestrel-only pill is not recommended as an alternative to COC in routine practice, but provides a useful alternative for women who require oestrogen-free contraception. In clinical trials: l Ovulation was inhibited in 97% of cycles at 7 and 12 months after initiation. l The Pearl index was 0.41 per 100 woman-years, which was not significantly different from a levonorgestrel-only pill. However, the trial providing these data was too small to detect a clinically important difference. -
Dose Response Effect of Cyclical Medroxyprogesterone on Blood Pressure in Postmenopausal Women
Journal of Human Hypertension (2001) 15, 313–321 2001 Nature Publishing Group All rights reserved 0950-9240/01 $15.00 www.nature.com/jhh ORIGINAL ARTICLE Dose response effect of cyclical medroxyprogesterone on blood pressure in postmenopausal women PJ Harvey1, D Molloy2, J Upton2 and LM Wing1 Departments of 1Clinical Pharmacology and 2Medicine, Flinders University of South Australia, Bedford Park, Adelaide, South Australia, Australia 5042 Objective: This study was designed to compare with mean values of weeks 3 and 4 of each phase used for placebo the dose-response effect of cyclical doses of analysis. Ambulatory BP was performed in the final the C21 progestogen, medroxyprogesterone acetate week of each phase. (MPA) on blood pressure (BP) when administered to Results: Compared with the placebo phase, end of normotensive postmenopausal women receiving a fixed phase clinic BP was unchanged by any of the proges- mid-range daily dose of conjugated equine oestrogen togen treatments. There was a dose-dependent (CEE). decrease in ambulatory daytime diastolic and mean Materials and methods: Twenty normotensive post- arterial BP with the progestogen treatments compared menopausal women (median age 53 years) participated with placebo (P Ͻ 0.05). in the study which used a double-blind crossover Conclusion: In a regimen of postmenopausal hormone design. There were four randomised treatment phases, replacement therapy with a fixed mid-range daily dose each of 4 weeks duration. The four blinded treatments of CEE combined with a cyclical regimen of a C21 pro- were MPA 2.5 mg, MPA 5 mg, MPA 10 mg and matching gestogen spanning the current clinical dose range, the placebo, taken for the last 14 days of each 28 day treat- progestogen has either no effect or a small dose-depen- ment cycle. -
Combined Estrogen–Progestogen Menopausal Therapy
COMBINED ESTROGEN–PROGESTOGEN MENOPAUSAL THERAPY Combined estrogen–progestogen menopausal therapy was considered by previous IARC Working Groups in 1998 and 2005 (IARC, 1999, 2007). Since that time, new data have become available, these have been incorporated into the Monograph, and taken into consideration in the present evaluation. 1. Exposure Data 1.1.2 Progestogens (a) Chlormadinone acetate Combined estrogen–progestogen meno- Chem. Abstr. Serv. Reg. No.: 302-22-7 pausal therapy involves the co-administration Chem. Abstr. Name: 17-(Acetyloxy)-6-chlo- of an estrogen and a progestogen to peri- or ropregna-4,6-diene-3,20-dione menopausal women. The use of estrogens with IUPAC Systematic Name: 6-Chloro-17-hy- progestogens has been recommended to prevent droxypregna-4,6-diene-3,20-dione, acetate the estrogen-associated risk of endometrial Synonyms: 17α-Acetoxy-6-chloro-4,6- cancer. Evidence from the Women’s Health pregnadiene-3,20-dione; 6-chloro-Δ6-17- Initiative (WHI) of adverse effects from the use acetoxyprogesterone; 6-chloro-Δ6-[17α] of a continuous combined estrogen–progestogen acetoxyprogesterone has affected prescribing. Patterns of exposure Structural and molecular formulae, and relative are also changing rapidly as the use of hormonal molecular mass therapy declines, the indications are restricted, O CH and the duration of the therapy is reduced (IARC, 3 C 2007). CH3 CH3 O C 1.1 Identification of the agents CH3 H O 1.1.1 Estrogens HH For Estrogens, see the Monograph on O Estrogen-only Menopausal Therapy in this Cl volume. C23H29ClO4 Relative molecular mass: 404.9 249 IARC MONOGRAPHS – 100A (b) Cyproterone acetate Structural and molecular formulae, and relative Chem. -
Australian Public Assessment Report for Progesterone
Australian Public Assessment Report for Progesterone Proprietary Product Name: Prometrium / Utrogestan Sponsor: Besins Healthcare Australia Pty Ltd June 2017 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) • The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating medicines and medical devices. • The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance) when necessary. • The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. • To report a problem with a medicine or medical device, please see the information on the TGA website <https://www.tga.gov.au>. About AusPARs • An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. • AusPARs are prepared and published by the TGA. • An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations and extensions of indications. • An AusPAR is a static document; it provides information that relates to a submission at a particular point in time. • A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA. -
Early Pregnancy Maternal Progesterone Administration Alters Pituitary and Testis Function and Steroid Profile in Male Fetuses
www.nature.com/scientificreports OPEN Early pregnancy maternal progesterone administration alters pituitary and testis function and steroid profle in male fetuses Katarzyna J. Siemienowicz1,2*, Yili Wang1, Magda Marečková1, Junko Nio‑Kobayashi1,3, Paul A. Fowler4, Mick T. Rae2 & W. Colin Duncan1 Maternal exposure to increased steroid hormones, including estrogens, androgens or glucocorticoids during pregnancy results in chronic conditions in ofspring that manifest in adulthood. Little is known about efects of progesterone administration in early pregnancy on fetal development. We hypothesised that maternal early pregnancy progesterone supplementation would increase fetal progesterone, afect progesterone target tissues in the developing fetal reproductive system and be metabolised to other bioactive steroids in the fetus. We investigated the efects of progesterone treatment during early pregnancy on maternal and fetal plasma progesterone concentrations, transcript abundance in the fetal pituitary and testes and circulating steroids, at day 75 gestation, using a clinically realistic ovine model. Endogenous progesterone concentrations were lower in male than female fetuses. Maternal progesterone administration increased male, but not female, fetal progesterone concentrations, also increasing circulating 11‑dehydrocorticosterone in male fetuses. Maternal progesterone administration altered fetal pituitary and testicular function in ovine male fetuses. This suggests that there may be fetal sex specifc efects of the use of progesterone in early pregnancy, and highlights that progesterone supplementation should be used only when there is clear evidence of efcacy and for as limited time as necessary. Fetal exposure to sex steroids has critical roles in sexual diferentiation and the programming of health and dis- ease in later life1. Exposure to endocrine disrupting compounds is linked to disease development in ofspring2. -
Progestogen Only Pills Sal Roberts RN RM Msc NDSRH PGA Med Ed (SRH) FRT Progestogen Only Contraception
Progestogen Only Pills Sal Roberts RN RM MSc NDSRH PGA Med Ed (SRH) FRT Progestogen Only Contraception • Implant • Pills • Injectables POC • No restrictions to use based purely on age • Can be used during lactation • Suitable for women with contraindications to estrogen containing contraceptives • No restrictions to use based purely on smoking history POP POPs can be divided into two categories: • Those that work primarily by a cervical mucus effect • Those that work primarily by inhibiting ovulation POP POPs That Work Primarily by a Cervical Mucus Effect: • primary mode of action is to cause thickening of cervical mucus, inhibiting sperm penetration into the upper reproductive tract • contain either norethisterone 350 μg (MicronorTM, NoridayTM) or levonorgestrel 30 μg (NorgestonTM) • referred to as traditional POPs • must be taken within three hours of the same time every day POP POPs That Work Primarily by Inhibiting Ovulation: • Desogestrel (DSG)-containing POPs work predominantly by suppressing ovulation • more effective than traditional POPs and may be less likely to be associated with follicular cysts and ectopic pregnancy • should be noted that ectopic pregnancy risk is lower with any type of POP than when using no contraception at all • appropriate for use for younger women or those with a history of symptomatic simple ovarian cysts • must be taken within 12 hours of the same time every day POP How effective?? • With consistent and correct use (i.e. 'perfect' use) the failure rate is <1%. However, 'typical' use gives a much higher failure rate of 8%. • No need for 2 pills for heavy women POP Suitability: As with all contraceptives, the clinician should take a full medical history to identify any conditions that fall within the UKMEC categories 3 or 4. -
Dosage and Administration
HGDS"'FG ·-···--··-· ..---- ·---·' .. e ·--··---····~·----- 133 Molesworth Street PO Box5013 Wellington 6140 New Zealand T +64 4 496 2000 1 February 2019 Response to your request for official information I refer to your request of 4 January 2019 to the Ministry of Health (the Ministry), under the Official Information Act 1982 (the Act), for. "I wish to request the following information regarding (the now lapsed) Aldactone, film coated tablets, spironolactone 25 mg and 100mg (TTS0-1764, 1764a): • Please provide a copy of the most recent datasheet (approved in a CMN or notified ina SACN). • Please provide a copy of the most recent primary and secondary labelling (approved in a CMN or notified in a SACN). • Please advise if the approved NZ labelling included an ARTG number." Information held by the Ministry relating to your request is itemised below, with copies of documents attached. Attachment Details and decision number - Data sheet for Aldactone 25 mg and Aldactone 100 mg. 1 Information released in full. Copy of the primary and secondary labelling for Aldactone 25 mg and 2 Aldactone 100 mg. Information released in full. In response to part three of your request, the Ministry confirms that the approved secondary labelling for Aldactone 25 mg and Aldactone 100 mg in New Zealand contained Australian Register of Therapeutic Goods (ARTG) numbers: AUST R 68953 (Aldactone 25 mg) and AUST R 68954 (Aldactone 100 mg). I trust this information fulfils your request. Please note this response (with your personal details removed) may be published on the Ministry of Health website. Yours si r;,c;:arely ~ r,,..~-~/___/ / /.. -
Allopregnanolone Effects in Women Clinical Studies in Relation to the Menstrual Cycle, Premenstrual Dysphoric Disorder and Oral Contraceptive Use
Umeå University Medical Dissertations, New Series No 1459 Allopregnanolone effects in women Clinical studies in relation to the menstrual cycle, premenstrual dysphoric disorder and oral contraceptive use Erika Timby Department of Clinical Sciences Obstetrics and Gynecology Umeå 2011 Responsible publisher under Swedish law: the Dean of the Medical Faculty This work is protected by the Swedish Copyright Legislation (Act 1960:729) ISBN: 978-91-7459-316-7 ISSN: 0346-6612 Front cover: Ceramic piece in raku technique by Charlotta Wallinder Elektronisk version tillgänglig på http://umu.diva-portal.org/ Tryck/Printed by: Print & Media, Umeå University Umeå, Sweden 2011 ”Morgon. Och sakerna förbi. Och HOTET som om det aldrig funnits. Hon var inte med barn och andra eftertankar behövdes inte.” Ur Lifsens rot av Sara Lidman Table of Contents Table of Contents i Abstract iii Abbreviations v Enkel sammanfattning på svenska vi Original papers ix Introduction 1 The menstrual cycle 1 Hormonal changes across the menstrual cycle 1 Brain plasticity across the menstrual cycle 2 Premenstrual symptoms and progesterone – a temporal relationship 3 Premenstrual symptoms in the clinic 3 Epidemiology of premenstrual symptoms/PMS/PMDD 3 The symptom diagnoses of PMDD and PMS 5 Comorbidity and risk factors in PMDD 6 Treatment options for PMDD 7 Trying to understand PMDD by in vivo and in vitro research 8 Etiological considerations in PMDD 8 Brain imaging in PMDD patients across the menstrual cycle 9 Connections between the GABA system and PMDD 10 Neurosteroids 12