ANNOVERA® is designed to continuously release a novel combination of hormones for 1 year. ANNOVERA is inserted
for 21 continuous days and removed 7 days for 13 cycles1
~150 mcg daily
~13 mcg daily
A Novel Progestin That Is:
Derived from progesterone2,3
Not derived from testosterone2,3
No androgenic activity. Androgenic activity can be responsible for changes in weight and acne2-5
Of the highest anti-ovulatory potential2,3
No Clinically Meaningful
Changes in Weight3
No Increased Risk in Vaginitis6*
In a sub-study of 110 women
ANNOVERA showed no increase in vaginitis, bacterial vaginosis, or yeast infections, and no changes in the vaginal flora after 13 cycles of use
Predictable Scheduled Bleeding7
In clinical trials of 2070 women:
98% of women had scheduled bleeding when used cyclically, with amenorrhea occurring in 2.6% to 4.9% of women per cycle
The mean number of bleeding-only days averaged 3.3 days
In clinical trials of 2308 women: 5-10% of females experienced unscheduled bleeding and/or spotting for ~1 day or less per 28-day cycle; 1.7% discontinued use due to irregular bleeding
The safety of ANNOVERA® was demonstrated in 3 open-label, 13-cycle clinical trials that enrolled 2308 women.
The following adverse events include any episode occurring in ≥5% of patients in the course of the 1-year study:
- Headache, including migraine
- Vaginal infections
- Abdominal pain
- Vaginal discharge
- Breast pain/tenderness/discomfort
- Genital pruritus
Adverse reactions leading to discontinuation by greater than or equal to 1% of ANNOVERA treated subjects:
- Metrorrhagia/menorrhagia (1.7%)
- Headache, including migraine (1.3%)
- Vaginal discharge/vulvovaginal infections (1.3%)
- Nausea/vomiting (1.2%)
- Annovera® [Full Prescribing Information]. Boca Raton, FL: TherapeuticsMD, Inc; 2020.
- Kumar N, Koide SS, Tsong YY, Sundaram K. Nestorone: a progestin with a unique pharmacological profile. Steroids. 2000; 54;629-636.
- Nelson A. Comprehensive overview of the recently FDA-approved contraceptive vaginal ring releasing segesterone acetate and ethinyl estradiol: a new year-long, patient controlled, reversible birth control method. Expert Rev Clin Pharmacol. 2019 Oct;12(10):953-963.
- Refn et al. Metabolic changes during treatment with two different progestogens. Am J Obstet Gynecol. 1990;163:374-377.
- Darney PD. The androgenicity of progestins. Am J Med. 1995;98(Suppl1A):104S-110S.
- Huang Y, Merkatz RB, Hillier SL, Roberts K, Blithe DL, Sitruk-Ware R, et al. (2015) PLOS ONE. 10(8): e0134460. doi:10.1371/journal.pone.0134460.
- 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. doi: 10.1016/j. contraception.2019.07.145