NCT02310802

OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI

A Phase 2, Double-blind, Dose-finding, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of OBE001 to Improve Embryo Implantation Following IVF or ICSI

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: ObsEva SA · Industry
• Sex: Female
• Age: 18 Years – 36 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the increase in clinical pregnancy rate after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist, compared to placebo.

Detailed description

The study is a prospective, dose-finding, randomised, parallel group, double-blind, placebo-controlled study investigating the efficacy and the safety of the oxytocin receptor antagonist OBE001 in 240 women undergoing embryo transfer following IVF or ICSI. The four-arm study (OBE001 dose 1, dose 2, dose 3, and placebo) design will allow evaluation of a possible dose-dependent pattern of action of OBE001 and, simultaneously, comparison of active compound with placebo with regard to both efficacy and safety.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	OBE001 dose 1	OBE001 dispersible tablets for single oral administration
DRUG	OBE001 dose 2	OBE001 dispersible tablets for single oral administration
DRUG	OBE001 dose 3	OBE001 dispersible tablets for single oral administration
DRUG	Placebo	Placebo dispersible tablets for single oral administration

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-11-01
• Completion: 2016-12-01
• First posted: 2014-12-08
• Last updated: 2017-10-23

Locations

18 sites across 6 countries: Belgium, Czechia, Denmark, Poland, Spain, United Kingdom