Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
|ClinicalTrials.gov Identifier: NCT00259103|
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : May 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Labor, Induced||Drug: Serelaxin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||November 2005|
|Primary Completion Date :||October 2006|
|Study Completion Date :||October 2006|
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.
- Cervical ripening [ Time Frame: Through 24 hours ]
- Progression to active labor and delivery [ Time Frame: Within 7 Days of Drug Infusion ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259103
|Novosibirsk State Medical Academy|
|Novosibirsk, Russian Federation|
|Saint Petersburg, Russian Federation, 199034|
|D.O. Ott Research Institute of Obstetrics and Gynecology|
|Saint Petersburg, Russian Federation|
|Study Director:||Sam Teichman, MD||Chief Medical Officer of BAS Medical, Inc.|