Owned And Operated
By Her With Confidence
Overall, nearly 90% of women in a clinical trial were satisfied with ANNOVERA® as a form of contraception. Most women rated ANNOVERA highly related to1*:
Most common adverse events2
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:
- Vaginal infections
- Abdominal pain
- Vaginal discharge
- Genital pruritus
Adverse reactions leading to discontinuation by ≥1% of ANNOVERA-treated subjects:
- Metrorrhagia/menorrhagia (1.7%)
- Headache, including migraine (1.3%)
- Vaginal discharge/vulvovaginal infections (1.3%)
- Nausea/vomiting (1.2%)
No clinically meaningful changes in weight3,4
Regular bleeding patterns2,5
In clinical trials of 2070 women:
- ~98% experienced scheduled bleeding when the ring was removed
— Amenorrhea was reported in 3-5% of cycles — 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
— Irregular bleeding was a common adverse reaction. For a full list of common adverse reactions, see the Full Prescribing Information
No alteration in vaginal ecosystem6
- 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
- In clinical studies of 2308 women, 1.3% discontinued use due to vaginal discharge or vulvovaginal infections
— Vulvovaginal infections and vaginal discharge were common adverse reactions. For a full list of common adverse reactions, see the Full Prescribing Information
High rate of adherence1†
- 94.3% of women used the ring as directed
- 1. 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. doi:10.1016/j. contraception.2014.05.015.
- 2. Annovera® [Full Prescribing Information]. Boca Raton, FL: TherapeuticsMD, Inc; 2020
- 3. Data on file 300A - Study Report Body. Population Council Inc. 2015.
- 4. Data on file 300B - Study Report Body. Population Council Inc. 2015.
- 5. 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.
- 6. Data on file. 300A - Microbiology Sub-Study. Population Council Inc. 2015.