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

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

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.

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