Trial | NCT02310802  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    nolasiban ...

  • Study Participants

    247
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.
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 Started
Nov 30
2014
Primary Completion
Nov 30
2015
Study Completion
Dec 31
2016
Last Update
Oct 23
2017

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

OBE001 dose 1 Experimental

OBE001 dose 2 Experimental

OBE001 dose 3 Experimental

Placebo Placebo Comparator

Criteria 

Key Inclusion Criteria

Women with medically indicated IVF or ICSI using her own oocytes.
GnRH antagonist protocol, a single injection of hCG for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.
Evidence of uterine contractions by transvaginal ultrasound at baseline.

Key Exclusion Criteria

Blastocyst stage or frozen-thaw transfers
Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results
Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome
No Results Posted