-Poster included analyses of ANNOVERA Phase 3 menstrual bleeding profile data-
“Menstrual bleeding patterns for women may change with contraceptive use, and predictable bleeding (cycle control) is a key factor that impacts women’s selection, adherence and continuation of combined hormonal contraception. In clinical studies, ANNOVERA showed predictable scheduled bleeding for most women. An unpredictable bleeding profile is very important because it is a common reason that women tend to switch among different contraceptives,” said
Results were pooled from two identically designed, open-label Phase 3 trials of ANNOVERA. Bleeding data were available from 2,070 women a total of 453,622 patient-days evaluated for bleeding. Based on ANNOVERA use for up to 13 cycles, a daily average of 94.8% to 97.6% of women reported no unscheduled bleeding in each cycle. The daily percentage of women presenting unscheduled bleeding (≤1.4%) or spotting (≤3.6%) was consistently low throughout the 13 cycles of ANNOVERA use. The median number of unscheduled bleeding/spotting days remained stable across the 13 cycles of ANNOVERA use. Less than 2% of women discontinued ANNOVERA due to bleeding-related adverse events.
ANNOVERA is the first and only FDA-approved long-lasting, reversible contraceptive for women of reproductive age that is patient-controlled and procedure-free. ANNOVERA was developed by the global non-profit research organization,
IMPORTANT RISK INFORMATION
- Do not use ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious heart and blood vessel (cardiovascular) side effects from hormonal birth control methods, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.
- ANNOVERA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
DO NOT USE ANNOVERA IF YOU
- have or have had a blood clot in your arms, legs, lungs, or eyes.
- have had a stroke.
- have reduced blood flow to your brain (cerebrovascular disease).
- have reduced blood flow or blockage in 1 or more of the arteries that supply blood to your heart (coronary artery disease).
- have had a heart attack.
- have heart rhythm or heart valve problems that increase your risk of having blood clots, such as an infection of the inner lining of the heart and heart valves or a type of irregular heartbeat called atrial fibrillation.
- have a problem with your blood that makes it clot more than normal.
- have high blood pressure that is not controlled with medicine or have high blood pressure with blood vessel damage.
- have diabetes and are over 35 years old; have diabetes with high blood pressure or problems with your kidneys, blood vessels, eyes, or nerves; or have had diabetes for longer than 20 years.
- have headaches with changes in vision, numbness or weakness, have migraine headaches with aura, or are over age 35 years old and have any type of migraine headaches.
- have liver disease or liver tumors.
- have or have had breast cancer or any cancer that is sensitive to the female hormones estrogen or progesterone.
- have unexplained vaginal bleeding.
- are allergic to segesterone acetate, ethinyl estradiol, or any of the ingredients in ANNOVERA.
- take any Hepatitis C drug combination medicine containing ombitasvir/paritaprevir/ ritonavir, with or without dasabuvir.
ANNOVERA can cause serious side effects, including: blood clots; toxic shock syndrome (TSS); liver problems, including liver tumors; high blood pressure; gallbladder problems; changes in the sugar and fat (cholesterol and triglycerides) levels in your blood; headache; irregular or unusual vaginal bleeding and spotting between your menstrual periods; depression; possible cancer in your cervix; swelling of your skin especially around your mouth, eyes, and in your throat (angioedema); dark patches of skin on your forehead, cheeks, upper lip, and chin (chloasma). Call your healthcare provider or get emergency medical care right away if any of these serious side effects occur.
The most common side effects of ANNOVERA include:
- headache, including migraine
- vaginal yeast infection (candidiasis)
- lower/upper abdomen pain
- painful periods
- vaginal discharge
- urinary tract infection
- breast pain/tenderness
- irregular vaginal bleeding
- genital itching
ANNOVERA is a ring-shaped vaginal system with hormones used by females to prevent pregnancy.
ANNOVERA has not been adequately studied in females with a body mass index >29 kg/m2.
The risk information provided here is not complete. To learn more, review the ANNOVERA Patient Information and talk with your healthcare provider or pharmacist. The FDA-approved product labeling, including Patient Information, can be found at annovera.com/pi.pdf.
You may report side effects to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
You may also report side effects to
Forward Looking Statements
This press release by
Vice President, Investor Relations
561-961-1900, ext. 2088