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Effect of Oxytocin Antagonist on Reduction of Uterine Contractions

NCT01043120 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2017-06-21

No results posted yet for this study

Summary

The main purpose of this clinical research trial was to evaluate the effects of barusiban compared to placebo on uterine contractions on luteal phase uterine contractions in oocyte donors supplemented with progesterone.

Conditions

  • In Vitro Fertilisation (IVF) Treatment

Interventions

DRUG

Barusiban

IV bolus of 20 mg for 1 minute followed by an IV infusion of 19 mg for up to 59 minutes. The maximum total duration of administration was 60 minutes.

DRUG

Placebo

IV bolus of saline (sodium chloride 0.9%) for 1 minute followed by an IV infusion of saline (sodium chloride 0.9%) for up to 59 minutes. Details on injection volume, infusion rates and doses are tabulated below.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
37 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-05-31
Completion
2010-12-31

Countries

  • Belgium
  • Czechia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT01043120 on ClinicalTrials.gov