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

Infertility Clinical Trial

— IMPLANT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310802
• Other study ID #: 14-OBE001-013
• Status: Completed
• Phase: Phase 2
• First received: November 19, 2014
• Last updated: October 20, 2017
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: ObsEva SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: December 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• OBE001 dose 1
OBE001 dispersible tablets for single oral administration
• OBE001 dose 2
OBE001 dispersible tablets for single oral administration
• OBE001 dose 3
OBE001 dispersible tablets for single oral administration
• Placebo
Placebo dispersible tablets for single oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ObsEva SA

Countries where clinical trial is conducted

Belgium,  Czechia,  Denmark,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SAFETY ENDPOINTS Treatment emergent adverse events frequency and severity	Treatment emergent adverse events frequency and severity	up to 10 weeks post OPU day
Other	SAFETY ENDPOINTS (Haematology and biochemistry assessments)	Haematology and biochemistry assessments at screening and at visit V3 (14 days post OPU day)	14 days post OPU day
Other	PHARMACOKINETIC ENDPOINTS Plasma levels of OBE001	Plasma levels of OBE001	at 3.5 hours after dose administration
Other	PHARMACOKINETIC-PHARMACODYNAMIC ENDPOINTS :Uterine contractions relationship to OBE001 plasma levels and pregnancy rate	Uterine contractions relationship to OBE001 plasma levels and pregnancy rate	up 10 weeks post OPU day
Primary	EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat	Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at about 6 weeks post ET day.	about 6 weeks post ET day
Secondary	EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test	Percentage of women with positive blood pregnancy test at 14 days post OPU day.	14 days post OPU day
Secondary	EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat	Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at 10 weeks post OPU day.	10 weeks post OPU day
Secondary	EFFICACY ENDPOINTS The embryo-implantation rate	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	6 weeks post ET day
Secondary	EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions	Change from baseline to the time of ET in the rate of uterine contractions (UC/min).	at 3.5 hours after dose administration