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

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: OBE001 dose 3; Drug: Placebo; Drug: OBE001 dose 2; Drug: OBE001 dose 1

• Registration Number: NCT02310802
• Lead Sponsor: ObsEva SA

Brief 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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-08
• Primary Completion: 2015-11
• Study Completion: 2016-12
• Disposition First Submitted: 2017-09-21
• Disposition First Submitted QC: 2017-09-21
• Disposition First Posted: 2017-09-28
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 247

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OBE001 dose 3	OBE001 dose 3	-
Placebo	Placebo	-
OBE001 dose 2	OBE001 dose 2	-
OBE001 dose 1	OBE001 dose 1	-

Primary Outcome Measures

Name	Time	Method
EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat	about 6 weeks post ET day	Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at about 6 weeks post ET day.

Secondary Outcome Measures

Name	Time	Method
EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test	14 days post OPU day	Percentage of women with positive blood pregnancy test at 14 days post OPU day.
EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat	10 weeks post OPU day	Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at 10 weeks post OPU day.
EFFICACY ENDPOINTS The embryo-implantation rate	6 weeks post ET day	The embryo-implantation rate defined as the number of intra-uterine embryos with positive heart-beat at 6 weeks post ET day divided by the number of embryos transferred
EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions	at 3.5 hours after dose administration	Change from baseline to the time of ET in the rate of uterine contractions (UC/min).