Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
The primary objective of this trial is to demonstrate the non-inferiority of the clinical
pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization
(IVF)/embryo transfer (ET) cycles in Japan (Japan Society of Obstetrics and Gynecology [JSOG]
2009 registry data: 24.3 percent [%]). The secondary objectives of this trial are to assess
the biochemical pregnancy rate per ET, pharmacokinetics, and safety of COL-1620.