Status:
COMPLETED
Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
Lead Sponsor:
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Conditions:
Labor, Induced
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Age between 18 and 40 years
- Normal pregnancy
- At least 40 weeks of gestation
- Otherwise healthy
Exclusion
- Anemia or hypertension
- Presence of chronic disease
- Endometriosis
- Known fetal anomaly
- Substance abuse
- History of cancer
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00259103
Start Date
November 1 2005
End Date
October 1 2006
Last Update
May 7 2014
Active Locations (3)
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1
Novosibirsk State Medical Academy
Novosibirsk, Russia
2
Evidence CPR
Saint Petersburg, Russia, 199034
3
D.O. Ott Research Institute of Obstetrics and Gynecology
Saint Petersburg, Russia