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Effect of Oxytocin and Vasopressin Antagonists on Uterine Contractions (OVANCON)

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ClinicalTrials.gov Identifier: NCT00587327
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
In Vitro Fertilisation (IVF) Treatment Drug: Barusiban Drug: Atosiban Drug: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel Groups, Placebo-controlled, Multi-centre Study Assessing the Effects of a Selective Oxytocin Antagonist (Barusiban) and a Mixed Oxytocin Antagonist - Vasopressin V1a Antagonist (Atosiban) Administered Intravenously on Luteal Phase Uterine Contractions in Oocyte Donors Supplemented With Vaginal Progesterone
Study Start Date : November 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Barusiban Drug: Barusiban
Solution for IV treatment. Bolus and infusion for 4 hours
Experimental: Atosiban Drug: Atosiban
Solution for IV administration. Bolus and infusion for 4 hours
Placebo Comparator: Placebo Drug: Placebo
Saline solution for IV administration. Bolus and infusion for 4 hours.



Primary Outcome Measures :
  1. Frequency of uterine contractions [ Time Frame: 3h after start of dosing ]

Secondary Outcome Measures :
  1. Period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions [ Time Frame: 3h after start of dosing ]
  2. Frequency, period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions [ Time Frame: 5 min, 15 min, 30 min, 1h, 1h 30 min, 2h, and 2h 30 min after start of dosing ]
  3. Frequency, period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions [ Time Frame: 5 min, 30 min, and 1h after mock embryo transfer ]
  4. Frequency, period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions [ Time Frame: 30 min and 1h post-dosing and on Day OR +5 ]
  5. Inter-subendometrial space [ Time Frame: 5 min, 15 min, 30 min, 1h, 1h 30 min, 2h, 2h 30 min, and 3h after start of dosing, at 5 min, 30 min, and 1h after mock embryo transfer, at 30 min and 1h post-dosing and on Day OR +5 ]
  6. Pharmacokinetic parameters of barusiban and atosiban [ Time Frame: 2 days after oocyte retrieval (Day OR +2, sampling throughout the day) and 5 days after oocyte retrieval (Day OR +5, one sampling) ]
  7. Population pharmacokinetic / pharmacodynamic model [ Time Frame: 30 min and 3h after start of dosing ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
Participants eligible for this trial were oocyte donors 18-35 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 (≥ 5,000 IU urinary hCG or 250 μg recombinant hCG) for triggering of final follicular maturation and had undergone oocyte retrieval with a yield of ≥ 6 cumulus-oocyte-complexes. Participants had given signed informed consent, were generally healthy and with a body mass index (BMI) of 18.5-29.9 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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587327


Locations
Belgium
UZ Brussel, Center for Reproductive Medicine
Brussels, Belgium
Czechia
Institute for Reproductive Medicine and Endocrinology
Pilsen, Czechia, 30177
ISCARE IVF a.s.
Prague, Czechia
Spain
Institut Universitari Dexeus
Barcelona, Spain, 08028
IVI Madrid
Madrid, Spain, 28035
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00587327     History of Changes
Other Study ID Numbers: FE200440 CS09
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Oxytocin
Atosiban
Vasopressins
Arginine Vasopressin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Tocolytic Agents