Discover ANNOVERA®

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Proven satisfaction

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*:

Ease-of-use

Comfort

Sexual activity

Expulsion

*In an ANNOVERA Phase 3 study, a product acceptability questionnaire was administered and completed at the end of Cycle 3 (n=1036). Results based on data from 905 subjects in the areas of ease-of-use, expulsion, side effects, and sex/intercourse. In clinical trials with 2308 women, the rate of expulsion was 25%. Expulsion occurred primarily in the first few weeks as women were getting used to the product, and resulted in 1.4% discontinuation.

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:

  • Headache,
    including migraine
  • Nausea/vomiting
  • Vaginal infections
  • Abdominal pain
  • Dysmenorrhea
  • Vaginal discharge
  • UTI
  • Metrorrhagia
  • Diarrhea
  • 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
In an ANNOVERA Phase 3 study, a product acceptability questionnaire was administered and completed at the end of Cycle 3 (n=1036).

References:

  • 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.

IMPORTANT SAFETY INFORMATION

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

See full prescribing information for complete boxed warning.

  • Females over 35 years old who smoke should not use ANNOVERA.
  • Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.

CONTRAINDICATIONS

ANNOVERA is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic diseases; current or history of breast cancer or other estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe (decompensated) cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the components of ANNOVERA; and use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.


WARNINGS AND PRECAUTIONS

  • Stop ANNOVERA if a thrombotic or thromboembolic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Start ANNOVERA no earlier than 4 weeks after delivery, in females who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years.
  • Discontinue if jaundice occurs.
  • Stop ANNOVERA prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir. ANNOVERA can be restarted 2 weeks following completion of this regimen.
  • Do not prescribe ANNOVERA for females with uncontrolled hypertension or hypertension with vascular disease. Monitor blood pressure and stop use if blood pressure rises significantly in females with well-controlled hypertension.
  • Monitor glucose in pre-diabetic or diabetic females taking ANNOVERA. Consider an alternate contraceptive method for females with uncontrolled dyslipidemias.
  • Patients using ANNOVERA who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated. ANNOVERA should be discontinued if indicated.
  • Other warnings include: gallbladder disease; depression; cervical cancer; increased serum concentrations of binding globulins; hereditary angioedema; chloasma (females who tend to develop chloasma should avoid exposure to the sun or UV radiation while using ANNOVERA); toxic shock syndrome (TSS) (if a patient exhibits symptoms of TSS, remove ANNOVERA, and initiate appropriate medical treatment); vaginal use (ANNOVERA may not be suitable for females with conditions that make the vagina more susceptible to vaginal irritation or ulceration).

ADVERSE REACTIONS

The most common adverse reactions reported in at least 5% of women who received ANNOVERA were: headache/migraine, nausea/vomiting, vulvovaginal mycotic infection/candidiasis, lower/upper abdominal pain, dysmenorrhea, vaginal discharge, urinary tract infection, breast pain/tenderness/discomfort, bleeding irregularities including metrorrhagia, diarrhea, and genital pruritus.


DRUG INTERACTIONS

Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of ANNOVERA or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with ANNOVERA.



INDICATION

ANNOVERA is a progestin/estrogen combination hormonal contraceptive indicated for use by females of reproductive potential to prevent pregnancy.


Limitations of Use: ANNOVERA has not been adequately studied in females with a body mass index >29 kg/m2.



Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING.



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