Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor - Full Text View

Sponsored by:	BAS Medical
Information provided by:	BAS Medical
ClinicalTrials.gov Identifier:	NCT00259103

Purpose

The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.

Condition	Intervention	Phase
Labor, Induced	Drug: recombinant human relaxin	Phase II

Drug Information available for: Relaxin Methocarbamol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety, Pharmacokinetics and Efficacy of Intravenous Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor

Further study details as provided by BAS Medical:

Primary Outcome Measures:

Cervical ripening

Secondary Outcome Measures:

Progression to active labor and delivery

Estimated Enrollment:	68
Study Start Date:	November 2005

Detailed Description:

A multicenter, randomized, double-blind, placebo-controlled, dose escalation study of healthy female subjects at ≥ 40 weeks gestation and who are scheduled for induction. A dose-escalation portion of the study is followed by a randomized, double-blind, placebo-controlled portion of the study. The endpoints include cervical ripening, as well as progression to labor and delivery.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 18 and 40 years
Normal pregnancy
At least 40 weeks of gestation
Otherwise healthy

Exclusion Criteria:

Anemia or hypertension
Presence of chronic disease
Endometriosis
Known fetal anomaly
Substance abuse
History of cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259103

Locations

Russian Federation
D.O. Ott Research Institute of Obstetrics and Gynecology
Saint Petersburg, Russian Federation
Novosibirsk State Medical Academy
Novosibirsk, Russian Federation
Evidence CPR
Saint Petersburg, Russian Federation, 199034

Sponsors and Collaborators

BAS Medical

Investigators

Study Director:

Sam Teichman, MD

Chief Medical Officer of BAS Medical, Inc.

More Information

Responsible Party:	BAS Medical ( Sam Teichman, Chief Medical Officer )
Study ID Numbers:	RLX.CR.001
Study First Received:	November 15, 2005
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00259103
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by BAS Medical:

relaxin
pregnancy
cervical ripening
normal pregnancy at least at 40 weeks of gestation

Study placed in the following topic categories:

Methocarbamol

Additional relevant MeSH terms:

Therapeutic Uses
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009