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

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00587327

Purpose

The main purpose of this clinical research study is to investigate if barusiban and/or atosiban can reduce the frequency of contractions in the womb at a time when fertilised eggs would be placed in the womb in patients undergoing IVF

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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 Vasopressins Atosiban Argipressin Barusiban

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Period, external, internal, and total contractile measure of uterine contractions. Frequency, period, external, internal, and total contractile measure [ Time Frame: 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:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Barusiban: Experimental	Drug: Barusiban Solution for IV treatment. Bolus and infusion for 4 hours
Atosiban: Experimental	Drug: Atosiban Solution for IV administration. Bolus and infusion for 4 hours
Placebo: Placebo Comparator	Drug: Placebo Saline solution for IV administration. Bolus and infusion for 4 hours.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Oocyte donors 18-35 years of age, who have undergone controlled ovarian hyperstimulation in the long GnRH agonist protocol or the multiple-dose or single-dose GnRH antagonist protocols, have received hCG (≥ 5,000 IU urinary hCG or 250 μg recombinant hCG) for triggering final follicular maturation and have underwent oocyte retrieval with a yield of ≥ 6 cumulus-oocyte-complexes.
Generally healthy subjects and with a BMI of 18.5-29.9 kg/m2.

Exclusion Criteria:

Subjects are excluded in case of endometriosis stage I-IV or uterine pathology. Subjects must be willing to not have intake of alcoholic beverages during the study, to not have sexual intercourse during the study, and to either maintain sexual abstinence or use a highly effective method of contraception from end-of-study 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
ISCARE IVF a.s.
Prague, Czech Republic
Institute for Reproductive Medicine and Endocrinology
Pilsen, Czech Republic, 30177
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 ( Hjort, Director )
Study ID Numbers:	FE200440 CS09
Study First Received:	December 21, 2007
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00587327 History of Changes
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment; Czech Republic: State Institute for Drug Control

Study placed in the following topic categories:

Arginine Vasopressin
Progesterone
Hormone Antagonists
Atosiban
Hormones, Hormone Substitutes, and Hormone Antagonists
Vasoconstrictor Agents

Vasopressins
Cardiovascular Agents
Hormones
Hemostatics
Oxytocin

Additional relevant MeSH terms:

Coagulants
Oxytocics
Hormone Antagonists
Atosiban
Hematologic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Cardiovascular Agents

Hemostatics
Pharmacologic Actions
Oxytocin
Tocolytic Agents
Natriuretic Agents
Therapeutic Uses
Vasopressins
Vasoconstrictor Agents
Antidiuretic Agents

ClinicalTrials.gov processed this record on July 06, 2009