Overview

This trial is active, not recruiting.

Condition infertility
Treatments obe001 dose 1, obe001 dose 2, obe001 dose 3, placebo
Phase phase 2
Sponsor ObsEva SA
Start date November 2014
End date November 2015
Trial size 240 participants
Trial identifier NCT02310802, 14-OBE001-013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
obe001 dose 1
OBE001 dispersible tablets for single oral administration
(Experimental)
obe001 dose 2
OBE001 dispersible tablets for single oral administration
(Experimental)
obe001 dose 3
OBE001 dispersible tablets for single oral administration
(Placebo Comparator)
placebo
Placebo dispersible tablets for single oral administration

Primary Outcomes

Measure
EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat
time frame: about 6 weeks post ET day

Secondary Outcomes

Measure
EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test
time frame: 14 days post OPU day
EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat
time frame: 10 weeks post OPU day
EFFICACY ENDPOINTS The embryo-implantation rate
time frame: 6 weeks post ET day
EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions
time frame: at 3.5 hours after dose administration

Eligibility Criteria

Female participants from 18 years up to 36 years old.

Key Inclusion Criteria 1. Women with medically indicated IVF or ICSI using her own oocytes. 2. GnRH antagonist protocol, a single injection of hCG for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone. 3. Evidence of uterine contractions by transvaginal ultrasound at baseline. Key Exclusion Criteria 1. Blastocyst stage or frozen-thaw transfers 2. Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results 3. Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by ObsEva SA.