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”

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

Study Type: Interventional

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

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.

Intervention(s) in this Clinical Trial

• Drug: recombinant human relaxin

Primary Measures

• Cervical ripening

Secondary Measures

• Progression to active labor and delivery

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: BAS Medical

Overall Clinical Trial Officials and Contacts

Sam Teichman, MD Study Director Chief Medical Officer of BAS Medical, Inc.  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00259103

Study ID Number: RLX.CR.001

ClinicalTrials.gov Identifier: NCT00259103

Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation