Effect of Oxytocin and Vasopressin Antagonists on Uterine Contractions - Full Text View

Purpose

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	Intervention	Phase
In Vitro Fertilisation (IVF) Treatment.	Drug: Barusiban Drug: Atosiban 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 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

Resource links provided by NLM:

Drug Information available for: Oxytocin Argipressin Vasopressin Atosiban Atosiban acetate

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Frequency of uterine contractions [ Time Frame: 3h after start of dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions [ Time Frame: 3h after start of dosing ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Population pharmacokinetic / pharmacodynamic model [ Time Frame: 30 min and 3h after start of dosing ] [ Designated as safety issue: No ]

Enrollment:	125
Study Start Date:	November 2007
Study Completion Date:	September 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587327

Locations

Belgium
UZ Brussel, Center for Reproductive Medicine
Brussels, Belgium
Czech Republic
Institute for Reproductive Medicine and Endocrinology
Pilsen, Czech Republic, 30177
ISCARE IVF a.s.
Prague, Czech Republic
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

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00587327 History of Changes
Other Study ID Numbers:	FE200440 CS09
Study First Received:	December 21, 2007
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:

Vasopressins
Oxytocin
Atosiban
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents

Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Oxytocics
Reproductive Control Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Tocolytic Agents

ClinicalTrials.gov processed this record on May 21, 2013

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