Effect of Oxytocin Antagonist on Reduction of Uterine Contractions (EFFORT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01043120
First received: January 5, 2010
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
In Vitro Fertilisation (IVF) Treatment.
Drug: Barusiban
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel Groups, Placebo-controlled, Multi-centre Trial in Oocyte Donors Assessing the Effects of Barusiban, a Selective Oxytocin Antagonist, on Uterine Contractions on the Day of Embryo Transfer

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Frequency of uterine contractions, Intention-To-Treat (ITT) Analysis Set [ Time Frame: 30 minutes after start of dosing ] [ Designated as safety issue: No ]
    Frequency of uterine contractions was assessed by transvaginal ultrasound. The transvaginal ultrasound recordings were analysed for uterine contractions by a central independent assessor, blinded to treatment allocation.

  • Frequency of uterine contractions, Per-Protocol (PP) Analysis Set [ Time Frame: 30 minutes after start of dosing ] [ Designated as safety issue: No ]
    Frequency of uterine contractions was assessed by transvaginal ultrasound. The transvaginal ultrasound recordings were analysed for uterine contractions by a central independent assessor, blinded to treatment allocation.


Secondary Outcome Measures:
  • Uterine contractile measures [ Time Frame: During and after dosing (one day) ] [ Designated as safety issue: No ]
  • Inter-endometrial space [ Time Frame: 30 minutes after start of dosing ] [ Designated as safety issue: No ]
  • Direction of Wave Propagation [ Designated as safety issue: No ]
  • Direction of Wave Propagation, Post-hoc analysis [ Time Frame: 30 min after start of dosing and MET ] [ Designated as safety issue: No ]
    Post-hoc analyses of the secondary endpoint parameter wave propagation were conducted. The ability of the contractile waves to propagate uterine contractions after mock embryo transfer was categorised (No, Yes, Indeterminate, NA or NE) by the central assessor for the following time points: Pre-dose, 30 min after start of dosing and at end of mock embryo transfer (MET0 min). Fisher's exact p-value test comparing the distribution of No and Yes between treatment groups was performed

  • Dispersion, Location, Distance from Point of Release and Velocity of Ultrasound Contrast Agent [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Barusiban 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.
Placebo Comparator: Placebo 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Participants eligible for this trial were oocyte donors 18-37 years of age, who had undergone controlled ovarian hyperstimulation in the long GnRH agonist protocol or the multiple-dose or single-dose GnRH antagonist protocols, had received hCG (10,000 IU urinary hCG or 250 μg recombinant hCG) for triggering of final follicular maturation and had undergone oocyte retrieval. Participants had given signed informed consent, were generally healthy and with a body mass index (BMI) of 18.5-29 kg/m2.

Participants were excluded in case of endometriosis stage I-IV or uterine pathology. Participants were willing to not have intake of alcoholic beverages during the trial, to not have sexual intercourse during the trial, and to either maintain sexual abstinence or use a highly effective method of contraception from end-of-trial till onset of next menses.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01043120

Locations
Belgium
UZ Brussel
Brussels, Belgium
Czech Republic
IVF Institute
Plzen, Czech Republic
ISCARE IVF a.s.
Prague, Czech Republic
Spain
IU Dexeus
Barcelona, Spain
IVI Madrid
Madrid, Spain
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01043120     History of Changes
Other Study ID Numbers: FE200440 CS11, 2009-012323-29
Study First Received: January 5, 2010
Last Updated: April 16, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Spain: Ethics Committee
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014