Annovera birth control vaginal ring effectively prevents unwanted pregnancy, research finds

March 26, 2019

NEW ORLEANS--A recently approved contraceptive vaginal ring--the first that can be used for an entire year--is a highly effective birth control method, according to clinical trial data that will be presented Tuesday at ENDO 2019, the Endocrine Society's annual meeting in New Orleans, La.

Approved last August by the Food and Drug Administration (FDA), Annovera is a self-inserted system marketed by TherapeuticsMD. The ring is left in place for 21 days and removed for 7 days in each cycle. It provides contraceptive efficacy for up to 13 cycles (1 year) of use. It is designed to release 150 mcg segesterone acetate and 13 mcg ethinyl estradiol per day and has a Pearl index, or failure rate, of 2.98.

"This rate means that only about three unintended pregnancies occur per 100 women in a year compared to a Pearl Index of 80 in couples not using a contraceptive method," said David F. Archer, M.D., an investigator in the Annovera multicenter clinical trials sponsored by the National Institute of Child Health and Human Development, which participated in the new data review.

Segesterone acetate is a new progestin that specifically binds to progesterone receptors. Unlike other combination hormone birth control products, it does not bind to sex hormone-binding globulin and has no estrogenic or androgenic activity. "We wanted to prove whether the segesterone in combination with the low dose of ethinyl estradiol in this unique vaginal system was adequate at inhibiting ovulation and pregnancy as well as providing good cycle control," Archer said.

The researchers reviewed data from earlier, dose-finding clinical trials that measured how long segesterone stayed in a woman's bloodstream and at what levels. Segesterone acetate serum levels above 105 pmol/L inhibited ovulation in the early trials. Segesterone acetate blood levels decreased only slightly over six months of use in a prior clinical trial with a progestin only ring, and when ethinyl estradiol was added to the ring, segesterone acetate blood levels were unchanged.

"The segesterone acetate release in the current vaginal ring effectively inhibits ovulation, resulting in the high level of contraceptive efficacy for this long-acting, reversible contraceptive," Archer said. He added that the ring's 97 percent success rate is comparable to the most effective birth control methods already on the market, which are at least 95 percent effective.

"Annovera represents a novel, procedure-free and long-acting reversible contraceptive method that can provide contraceptive benefits for up to one year," Archer said.
The Population Council developed the Annovera vaginal ring co-sponsored the clinical trials and licensed the product to TherapeuticsMD.

Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. The Endocrine Society is the world's oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.

The Society has more than 18,000 members, including scientists, physicians, educators, nurses and students in 122 countries. To learn more about the Society and the field of endocrinology, visit our site at Follow us on Twitter at @TheEndoSociety and @EndoMedia.

The Endocrine Society

Related Clinical Trial Data Articles from Brightsurf:

First entirely digital clinical trial encourages physical activity
As little as a daily ping on your phone can boost physical activity, researchers from the Stanford University School of Medicine and their collaborators report in a new study.

Yale-developed scorecard promotes better clinical trial data sharing
A tool developed by researchers at Yale, Stanford, and Bioethics International can promote greater sharing of clinical trial data by pharmaceutical companies.

Meditation goes digital in new clinical trial
Scientists at UC San Francisco have developed a personalized digital meditation training program that significantly improved attention and memory in healthy young adults -- a group already at the peak of brain health -- in just six weeks.

Could blockchain ensure integrity of clinical trial data?
UC San Francisco researchers have created a proof-of-concept method for ensuring the integrity of clinical trials data with blockchain.

Early clinical trial data show gene therapy reversing sickle cell anemia
After over a decade of preclinical research and development, a new gene therapy treatment for Sickle Cell Anemia (SCA) is reversing disease symptoms in two adults and showing early potential for transportability to resource-challenged parts of the world where SCA is most common.

Most clinical trial participants find benefits of sharing personal data outweigh risks
Most participants in clinical trials believe the benefits of broadly sharing person-level data outweigh the risks, according to a new study by Stanford University researchers.

Idera Pharmaceuticals presents clinical data from the ILLUMINATE-204 trial of the combination of tilsotolimod and ipilimumab for anti-PD-1 refractory metastatic melanoma at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting
Idera Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with rare cancers and rare diseases, announced results from the ongoing ILLUMINATE-204 trial investigating tilsotolimod, Idera's intratumorally-delivered Toll-like Receptor 9 agonist, in combination with ipilimumab (Yervoy®).

Spark Therapeutics and Pfizer announce publication in The New England Journal of Medicine of Interim Data from phase 1/2 clinical trial of investigational gene therapy for Hemophilia B
Spark Therapeutics (NASDAQ: ONCE), a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, and Pfizer Inc.

Clinical trial eligibility criteria a growing obstacle
Despite a decade-long call for simplification of clinical trials, the number of criteria excluding patients from participating in clinical trials for lung cancer research continues to rise.

Spark Therapeutics announces publication in The Lancet of pivotal Phase 3 clinical trial data for investigational voretigene neparvovec
Spark Therapeutics (NASDAQ: ONCE), a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, today announced The Lancet, a highly ranked peer-reviewed journal, has published Phase 3 clinical trial data of voretigene neparvovec, an investigational, potential one-time gene therapy candidate for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease (IRD).

Read More: Clinical Trial Data News and Clinical Trial Data Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to