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

Tracking Information

First Received Date ^ICMJE

November 15, 2005

Last Updated Date

April 21, 2008

Start Date ^ICMJE

November 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Cervical ripening

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00259103 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression to active labor and delivery

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Labor, Induced

Intervention ^ICMJE

Drug: recombinant human relaxin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Russian Federation

Administrative Information

NCT ID ^ICMJE

NCT00259103

Responsible Party

Sam Teichman, Chief Medical Officer, BAS Medical

Study ID Numbers ^ICMJE

RLX.CR.001

Study Sponsor ^ICMJE

Corthera, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Sam Teichman, MD

Chief Medical Officer of BAS Medical, Inc.

Information Provided By

Corthera, Inc.

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP