Segesterone Acetate and Ethinyl Estradiol Vaginal Ring (Annovera) for Contraception

Amy L. Lee

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May 15, 2020 Issue

STEPS

New Drug Reviews

Segesterone Acetate and Ethinyl Estradiol Vaginal Ring (Annovera) for Contraception

AMY L. LEE, MD, FAAFP, Tufts University School of Medicine, Boston, Massachusetts

Am Fam Physician. 2020 May 15;101(10):618-620.

The segesterone acetate and ethinyl estradiol vaginal ring (Annovera) is a combined progestin/estrogen silicone elastomer device labeled to prevent pregnancy in women of reproductive age with a body mass index less than 29 kg per m². The same ring can be used for one year.

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Drug	Dosing	Dose form	Cost*
Segesterone acetate and ethinyl estradiol vaginal ring (Annovera)	Insert ring vaginally for 21 days, then remove for seven days†	Vaginal ring: 103 mg/17.4 mg (0.15 mg/0.013 mg per day)	$2,000 for one ring

*—Estimated lowest GoodRx price for one year of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.goodrx.com (accessed April 2, 2020; zip code: 66211).

†—Annovera can be used for 13 28-day cycles. Wash and store when not in use.

Drug	Dosing	Dose form	Cost*
Segesterone acetate and ethinyl estradiol vaginal ring (Annovera)	Insert ring vaginally for 21 days, then remove for seven days†	Vaginal ring: 103 mg/17.4 mg (0.15 mg/0.013 mg per day)	$2,000 for one ring

†—Annovera can be used for 13 28-day cycles. Wash and store when not in use.

Safety

Safety of Annovera has been assessed in 2,308 women, 999 of whom completed a full year of treatment. Serious adverse effects appear to be similar to those of other combined hormonal contraceptives and include thrombosis, myocardial infarction, stroke, carcinoma, gallbladder disease, liver disease, dyslipidemia, and hypertension.1,2 Because segesterone acetate is a new progesterone, there are limited safety data, and postmarketing studies are ongoing. Women older than 35 years who smoke should avoid using Annovera because of the increased risk of serious cardiovascular events. Breastfeeding women should avoid this form of contraception because it can decrease milk production. It should not be used during pregnancy.

Tolerability

Adverse effects occur in at least 5% of women and include headache, nausea, vaginal discharge, dysmenorrhea, breast discomfort, and irregular bleeding.1 Over the course of one year, about one in eight women will discontinue use of Annovera because of adverse

Address correspondence to Amy L. Lee, MD, FAAFP, at amy.lee@tufts.edu. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

References

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1. DailyMed. Drug label information. Annovera—segesterone acetate and ethinyl estradiol ring. Accessed November 29, 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=37bb9ebd-2e99-4453-bbe6-9dd4a2897193...

2. Archer DF, Merkatz RB, Bahamondes L, et al. Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multi-centre, open-label, single-arm, phase 3 trials. Lancet Glob Health. 2019;7(8):e1054–e1064.

3. DailyMed. Drug label information. Nuvaring—etonogestrel and ethinyl estradiol insert, extended release. Accessed November 29, 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=017343fb-86c4-45ab-9c47-52cc5b9f3a02

4. Gerlinger C, Trussell J, Mellinger U, et al. Different Pearl Indices in studies of hormonal contraceptives in the United States: impact of study population. Contraception. 2014;90(2):142–146.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

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