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

Labor, Induced Clinical Trial

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 Labour

Clinical Trial Summary

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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00259103
Study type Interventional
Source Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Contact
Status Completed
Phase Phase 2
Start date November 2005
Completion date October 2006
View Details
See also
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