June 20, 2019—The Lancet Global Health today published results from the Phase 3 clinical efficacy trials of the Population Council-developed Annovera™ (segesterone acetate and ethinyl estradiol vaginal contraceptive system).
Annovera is the first and only contraceptive that provides an entire year of protection against unintended pregnancy while fully under a woman’s control. Results show that Annovera was 97% effective in preventing pregnancy for up to 13 menstrual cycles, which means that women do not need to return to the clinic or pharmacy for prescription refills.
Annovera, which was approved by the U.S. Food and Drug Administration (FDA) in August 2018, is the first in a potential new class of contraceptives. The soft, flexible, silicone vaginal ring contains segesterone acetate (Nestorone) and a widely used estrogen (ethinyl estradiol). Annovera has not been adequately evaluated in women with a body mass index (BMI) greater than 29 kg/m2.
“Publication of these efficacy results reinforce the evidence base around Annovera as an effective contraceptive option, and its potential role in family planning,” said Population Council Distinguished Scientist, Regine Sitruk-Ware, who co-authored the efficacy paper. “What’s exciting about these results is that we are seeing that this new progestin, when combined with an estrogen commonly used in combination hormonal contraceptives, provides high rates of protection from unintended pregnancy.”
Results of the pivotal Phase 3 studies published today showed an overall Pearl Index of 2.98 (95% CI 2·13–4·06). Additional Phase 3 results published in the journal Contraception earlier this year showed that Annovera offers a safety risk profile similar to other combination hormonal contraceptives, including a boxed warning about cigarette smoking and serious cardiovascular events. Results from the Annovera Phase 3 program, which enrolled 2,308 women between 18 and 40 years of age across 27 sites in the United States, Latin America, Europe, and Australia, were part of the documentation reviewed by the FDA for marketing authorization.
Annovera is inserted and removed by the woman herself for each 28-day cycle, offering the convenience of longer-acting contraceptive methods that do not require daily administration, and can be discontinued without a clinical visit. It also does not require refrigeration, which is especially important for distribution and use in low- and middle-income countries.
“Annovera may be a particularly attractive option for women in low-resource settings,” said Jim Sailer, vice president and executive director of the Population Council’s Center for Biomedical Research. “We are continuing to explore ways to make Annovera available to women worldwide, including in low- and middle-income countries where more than 214 million women have an unmet need for contraception.”
The Population Council has a license agreement with TherapeuticsMD, an innovative healthcare company focused on developing and commercializing novel products exclusively for women, to make Annovera available in the US. Annovera is the sixth technology to prevent unintended pregnancy that Council researchers have brought to market through commercialization partnerships.
Annovera represents the latest in the Population Council’s efforts to leverage rigorous biomedical and social and behavioral science research to advance rights, enhance quality, and improve lives around the world. We estimate that more than 170 million women worldwide are currently using contraceptives developed by or based on Population Council technology.
Important public and private donors from around the world have supported the research and development of Annovera, including the United States Agency for International Development (USAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Bill & Melinda Gates Foundation, the Avis and Clifford Barrus Medical Foundation, the World Health Organization (WHO), and the Population Council. The Phase 3 trials were conducted by the Population Council and the Contraceptive Clinical Trials Network (CCTN) of the NICHD.
ANNOVERA IMPORTANT SAFETY INFORMATION
ANNOVERA is a progestin/estrogen combination hormonal contraceptive (CHC) indicated for use by females of reproductive potential to prevent pregnancy. (Limitation of use: Not adequately evaluated in females with a BMI of > 29 kg/m2).
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of cardiovascular events from CHC use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. CHCs should not be used by females who are over 35 years of age and smoke.
Due to increased risks of serious side effects, ANNOVERA should not be used in females with certain medical conditions, including females who have a high risk of arterial or venous thrombotic diseases; who have or have had breast cancer or other estrogen- or progestin-sensitive cancer; who have liver tumors, acute hepatitis, severe cirrhosis, undiagnosed abnormal uterine bleeding, or hypersensitivity to any ingredients in ANNOVERA; who use certain Hepatitis C drug combinations; or who are pregnant or breastfeeding.
Risks from use of a CHC, like ANNOVERA, particularly in females with any condition listed above, include venous thrombotic events; cardiovascular events and cerebrovascular events such as stroke and myocardial infarction; liver disease; elevated liver enzymes with concomitant Hepatitis C treatment; hypertension; carbohydrate and lipid metabolic effects; headache; bleeding irregularities and amenorrhea.
ANNOVERA does not protect against HIV-infection (AIDS) and other sexually transmitted infections.
Please note that this information is not comprehensive. Please see the Full Prescribing Information, including the Boxed Warning, for ANNOVERA at www.annovera.com/pi.pdf.