NCT00259103

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Labor, Induced

Interventions

Type	Name	Description
DRUG	Serelaxin
DRUG	Placebo

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2005-11-29
• Last updated: 2014-05-07

Locations

3 sites across 1 country: Russia