Teva Women’s Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), today announced findings from a Phase III clinical trial of Milprosa TM (progesterone), an investigational weekly progesterone vaginal ring for luteal supplementation in women undergoing in vitro fertilization (IVF). These data were presented as an oral presentation at the 68 th Annual Meeting of the American Society for Reproductive Medicine (ASRM).
Data from a randomized, single-blind trial assessing the pregnancy rate of Milprosa™ versus daily 8 percent progesterone gel for luteal supplementation in women undergoing embryo transfer during IVF at days three and five were presented. Results showed clinical pregnancy rates for Milprosa™ were similar to progesterone gel, regardless of the day the embryos were returned to the uterus. Researchers concluded that Milprosa™ is effective in luteal supplementation in IVF and that clinical pregnancy rates were similar for the vaginal ring and 8 percent progesterone gel. 1
“We are encouraged by the data presented on Milprosa™ at ASRM this year, which demonstrated that the vaginal progesterone ring may provide an appropriate option for luteal phase support in IVF,” said Mark Perloe, MD, medical director at Georgia Reproductive Specialists. “We look forward to having a new once-weekly option available for patients going through IVF. i
Additionally, results from a patient satisfaction survey, which were part of the Phase III clinical trial, were also presented in a poster at ASRM. The survey assessed all 1,297 women in the trial, who used either Milprosa™ or progesterone gel. Of these women, 262 had used at least one progesterone treatment in a previous IVF cycle prior to entering the Phase III study. Prior progesterone treatments used included injection, oral/vaginal capsule, gel or another method. When comparing their randomized treatment to former methods, women randomized to Milprosa™ more frequently reported their randomized treatment as a method that was more convenient, less messy, less stressful and causing less leakage. 2“We are pleased to have promising data on Milprosa™ presented at ASRM that builds upon our heritage in women’s reproductive health products,” said Nancy Ricciotti, senior director of clinical affairs, Teva Women’s Health R&D. “IVF represents a new area of specialization for Teva and one in which significant unmet needs exist. We hope to use our legacy in women’s health to help women dealing with infertility achieve their reproductive goals.”