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

NCT02310802 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2017-10-23

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • ObsEva SA

    lead INDUSTRY

Principal Investigators

  • Clinical Study Director · ObsEva SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-11-30
Completion
2016-12-31

Countries

  • Belgium
  • Czechia
  • Denmark
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02310802 on ClinicalTrials.gov