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

Phase 2

Completed

• Conditions: Labor, Induced
• Interventions: Drug: Placebo; Drug: Serelaxin

• Registration Number: NCT00259103
• Lead Sponsor: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

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 Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-15
• Study First Submitted QC: 2005-11-28
• Study First Posted: 2005-11-29
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-06
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants who received IV infusion of placebo, some during part A and others during part B.
7.5 µg/kg/d	Serelaxin	Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A.
25 µg/kg/d	Serelaxin	Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A.
75 µg/kg/d	Serelaxin	Participants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B.

Primary Outcome Measures

Name	Time	Method
Cervical ripening	Through 24 hours

Secondary Outcome Measures

Name	Time	Method
Progression to active labor and delivery	Within 7 Days of Drug Infusion

Trial Locations

Locations (3)

D.O. Ott Research Institute of Obstetrics and Gynecology; 🇷🇺 Saint Petersburg, Russian Federation

Novosibirsk State Medical Academy; 🇷🇺 Novosibirsk, Russian Federation

Evidence CPR; 🇷🇺 Saint Petersburg, Russian Federation