Type of information: Initiation of the trial
Announcement: initiation of the trial
Company: Bayer Healthcare (Germany)
Product: vilaprisan (BAY1002670)
Action mechanism: selective progesterone receptor modulator (SPRM). Vilaprisan (BAY1002670), discovered at Bayer, is a novel oral, selective progesterone receptor modulator (SPRM) which may allow for effective long-term treatment of uterine fibroids.
Disease: symptomatic uterine fibroids
Therapeutic area: Gynecology - Women's health
Country: China, Colombia, Czechia, Finland, Hong Kong, Japan, Mexico, Norway, Poland, Russian Federation, South Africa, Spain, Turkey, USA
Trial details: The study is performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care. (NCT03194646)
Latest news: • On July 3, 2017 , Bayer announced that the first patient was enrolled in a Phase III clinical study program ASTEROID which will investigate vilaprisan in women suffering from uterine fibroids. The planned ASTEROID Phase III clinical study program will include several studies to investigate the efficacy and safety of vilaprisan 2mg in patients with symptomatic uterine fibroids. The program aims at enrolling more than 3600 patients at about 900 centres in about 40 countries and it is anticipated that it will take 3 years to complete the progam. Efficacy measures to be assessed within the trial program will include the effect on heavy menstrual bleeding (amenorrhea rate, controlled bleeding), reduction in fibroid size and improvement in quality of life. The design and dosing of the Phase III clinical study program was based on results from the ASTEROID Phase II clinical study program (ASTEROID 1+2) investigating vilaprisan in patients with symptomatic uterine fibroids. ASTEROID 1 was a Phase IIb study that investigated the efficacy and safety of four different doses of vilaprisan compared to placebo in patients with symptomatic uterine fibroids; results were presented at the 72nd American Society of Reproductive Medicine (ASRM) 2016 Scientific Congress & Expo in Salt Lake City, UT, USA. ASTEROID 2 was a Phase IIb study that assessed the efficacy and safety of vilaprisan in patients with symptomatic uterine fibroids compared to placebo and ulipristal acetate (Esmya®). First results of ASTEROID 2 will be presented at an upcoming scientific congress.