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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Cervical ripening [ Time Frame: Through 24 hours ] [ Designated as safety issue: No ]
- Progression to active labor and delivery [ Time Frame: Within 7 Days of Drug Infusion ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Experimental: 7.5 µg/kg/d
Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A.
Experimental: 25 µg/kg/d
Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A.
Experimental: 75 µg/kg/d
Participants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B.
Participants who received IV infusion of placebo, some during part A and others during part B.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259103
|Novosibirsk State Medical Academy|
|Novosibirsk, Russian Federation|
|D.O. Ott Research Institute of Obstetrics and Gynecology|
|Saint Petersburg, Russian Federation|
|Saint Petersburg, Russian Federation, 199034|
|Study Director:||Sam Teichman, MD||Chief Medical Officer of BAS Medical, Inc.|