Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
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|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|
|Actual Primary Completion Date :||October 2006|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|