Phase 3 Trial Update of Milprosa for Luteal Supplementation in IVF

Teva announced findings from a Phase 3 clinical trial of Milprosa (progesterone) for luteal supplementation in women undergoing in vitro fertilization (IVF).

Data from a randomized, single-blind trial assessing the pregnancy rate of Milprosa vs. daily 8% progesterone gel for luteal supplementation in women undergoing embryo transfer during IVF at Days Three and Five were announced. 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% progesterone gel.

Additionally, results from a patient satisfaction survey, which were part of the Phase 3 clinical trial, were also announced. 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 3 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.

An investigational once-weekly progesterone vaginal ring, Milprosa is a flexible transvaginal ring that is designed to continuously release a steady dose of progesterone.

For more information call (215) 591-3000 or visit www.tevapharm.com.