Annovera: The First Long-Lasting, Reversible Contraception that is Patient Controlled and Procedure Free
Providing a Long-Lasting Supply of Contraception May Lead to More Consistent Use and Reduction in Unintended Pregnancies
Published as a promotional supplement to Contemporary OB/GYN.
Sponsored by: TherapeuticsMD
Of all unintended pregnancies, 41% are due to the inconsistent use of contraceptives.1 The Centers for Disease Control and Prevention recommend that women be provided with a 1-year supply of birth control.2 Birth control pills, patches, one-month rings, and injections are typically dispensed in only 1- or 3-month supplies, making additional trips to a clinic or pharmacy a potential barrier to consistent use. Women who receive a 1-year supply of birth control have been found to be 30% less likely to have an unintended pregnancy compared with women receiving a 1- to 3-month supply.3,4 Long-acting reversible contraception (LARC) methods such as intrauterine devices (IUDs) and implants must be administered by a healthcare professional and require a procedure for insertion and removal.
Annovera (segesterone acetate and ethinyl estradiol vaginal system)
The segesterone acetate and ethinyl estradiol vaginal system was developed to address the needs of women who desire a long-lasting form of birth control without requiring a procedure for insertion and removal coupled with the patient control and immediate reversibility aspect of short-acting products (Figure).
Figure
It is a soft, flexible vaginal ring that is self-administered and does not require a procedure. Although the overall diameter is roughly the same as NuvaRing (etonogestrel/ethinyl estradiol vaginal ring), the increase in its width was purposeful because it is composed of a “squishy” silicone elastomer to make it soft and flexible for easy insertion and removal while remaining comfortably in place throughout daily activities including sex.5,6 It is inserted into the vagina and remains in place for 21 days and then removed for 7 days each cycle. It can be used for up to a full year or 13 menstrual cycles.5 It is also as effective as a pill without the daily commitment. In clinical trials, the 13-cycle (1-year) cumulative probability of not becoming pregnant was 97.3%.5 Unlike other contraceptive vaginal rings, it does not require refrigeration at any time.
Created with a novel hormonal profile
This ring-shaped vaginal system contains two active hormones, releasing one of the lowest daily doses of ethinyl estradiol (13 mcg/day) and including a new nonandrogenic progestin, segesterone acetate. Unlike the other progestins contained in combination hormonal contraceptives that are all derived from testosterone, segesterone acetate is derived from natural progesterone. Segesterone acetate is of the highest anti-ovulatory potency and unlike other progestins, it demonstrates no androgenic or glucocorticoid activity that can be responsible for changes in weight and acne.7,8* Based on the residual amount of drug in the productused in clinical trials over 13 cycles, approximately 40% (41.2 mg) of segesterone acetate and 20% (3.48 mg) of ethinyl estradiol were released over this period.5
Cycle control – Bleeding profile
In clinical trials of 2070 women, 98% of women had scheduled bleeding with amenorrhea occurring in 2.6% to 4.9% of women per cycle.9 The mean number of bleeding-only days averaged 3.3 days.9 Unscheduled bleeding or spotting occurred in 5% to 10% of women and lasted for an average of 1 day or less per cycle.9
Patient acceptability
Overall satisfaction with this form of contraception was approximately 90%.10† No clinically relevant increase in weight or other androgenic side effects were observed.8,11 Its use did not increase the risk of vaginal infection nor did it affect the vaginal microbiome.12‡ There were no increases in bacterial vaginosis, candidiasis, or trichomoniasis throughout the study.12‡
Adverse reactions
Safety was demonstrated in 3 open-label, 13-cycle (1-year) clinical trials that enrolled 2308 women.11
Adverse events occurred most frequently within the first days of the first cycle and were both mild and self-limiting (Table). Expulsion occurred primarily in the first few weeks as women were getting used to the product and resulted in 1.4% discontinuation.
How to start
- Women not using hormonal contraception should start between days 2 and 5 of their menstrual cycle—no back-up contraception is needed.5
- Women consistently using the pill, patch, or ring can switch at any time, provided there has been no break in usage without requiring a back-up method.5
- Women switching from a progestin-only method, including pill, IUD, injection, or implant, may switch at any time, but a back-up method should be used for the first 7 days of use.5
Patient types
The segesterone acetate and ethinyl estradiol vaginal system is ideal for women who want to be in control of both their fertility and menstruation with a 21/7 cyclical, self-administered, long-lasting product with immediate reversibility. It should be considered for adolescents or anyone who does not want to take a product every day and does not want a procedure. It is appropriate for nulliparous women and those not in a monogamous relationship who in the past may have been denied LARCs; women who are birth spacing and in-between children who do not want to commit to a contraceptive of longer duration; college women with unpredictable schedules who do not want a daily-use product or worry about getting their monthly refills; women in the military who want control of fertility and menstruation for 1 year; and women who are approaching menopause and still want contraception. It represents a single contraceptive product amenable for most patient and prescriber types.
Conclusion
The segesterone acetate and ethinyl estradiol vaginal system is the only long-lasting reversible contraception that is procedure free, used for 21/7 day cyclical dosing for one year (13 cycles), empowering women to be in control of their fertility and menstruation.5 It contains a nonandrogenic progestin, segesterone acetate,with the highest anti-ovulatory that has no androgenic or glucocorticoid effects at contraceptive doses.7,8* It also has one of the lowest average daily releases of ethinyl estradiol (13 mcg/day), and users report high patient satisfaction (~90%).5,10† Women should be counseled about its unique features when discussing their birth control options.
To learn more about the segesterone acetate and ethinyl estradiol vaginal system, visit annoverahcp.com.
Please see brief summary of Full Prescribing Information, including BOXED WARNING, on the following page or visit annovera.com/pi.pdf.
*Based on pharmacologic studies in animals and in vitro studies. The clinical significance of these data is not known.
†In a phase 3 study, a product acceptability questionnaire was administered and completed at the end of Cycle 3 (n=1036). Results were based on data from 905 subjects in the areas of ease of use, expulsion, side effects, and sex/intercourse.
‡Vulvovaginal infections and vaginal discharge were common adverse reactions. For a full list of common adverse reactions, see table above or review the Full Prescribing Information.
References
1. Sonfield A, Hasstedt K, Gold RB. Moving forward: family planning in the era of health reform. Guttmacher Institute, 2014.
2. Centers for Disease Control and Prevention. Reproductive health. Combined hormonal contraceptives. Available at https://www.cdc.gov/reproductivehealth/contraception/mmwr/spr/combined.html. Accessed August 26, 2020.
3. Foster DG, Hulett D, Bradsberry M, et al. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol. 2011;117(3):566-572.
4. McMenamin SB, Charles SA, Tabatabaeepour N, et al. Implications of dispensing self-administered hormonal contraceptives in a 1-year supply: a California case study. Contraception. 2017;95(5):449-451.
5. Annovera [package insert]. Boca Raton, FL: TherapeuticsMD, Inc; 2020.
6. NuvaRing [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme: 2001.
7. Kumar N, Koide SS, Tsong Y, Sundaram K. Nestorone: a progestin with a unique pharmacological profile. Steroids. 2000;65(10-11):629-636.
8. Nelson A. Comprehensive overview of the recently FDA-approved contraceptive vaginal ring releasing segesterone acetate and ethinylestradiol: a new year-long, patient controlled, reversible birth control method. Expert Rev Clin Pharmacol. 2019;12(10):953-963.
9. Vieira CS, Fraser IS, Plagianos MG, et al. Bleeding profile associated with 1-year use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system: pooled analysis from phase 3 trials. Contraception. 2019;100(6):438-444.
10. Merkatz RB, Plagianos M, Hoskin E, et al. Acceptability of the Nestorone/ethinyl estradiol contraceptive vaginal ring: development of a model; implications for introduction. Contraception. 2014;90(5):514-521.
11. Gemzell-Danielsson K, Sitruk-Ware R, Creinin MD, et al. Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation. Contraception. 2019;99(6):323-328.
12. Huang Y, Merkatz RB, Hillier SL, et al. Effects of a one year reusable contraceptive vaginal ring on vaginal microflora and the risk of vaginal infection: an open-label prospective evaluation. PLoS One. 2015;10(8):e0134460. DOI:10.1371/journal.pone.0134460
13. Tibaijuka L, Odongo R, Welikhe E, et al. Factors influencing use of long-acting versus short-acting contraceptive methods among reproductive-age women in a resource-limited setting. BMC Women’s Health. 2017;17(1):25. doi:10.1186/s12905-017-0382-2.
