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

This study has been completed.
Sponsor:
Information provided by:
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
ClinicalTrials.gov Identifier:
NCT00259103
First received: November 15, 2005
Last updated: April 21, 2008
Last verified: April 2008

November 15, 2005
April 21, 2008
November 2005
Not Provided
Cervical ripening
Same as current
Complete list of historical versions of study NCT00259103 on ClinicalTrials.gov Archive Site
Progression to active labor and delivery
Same as current
Not Provided
Not Provided
 
Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
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 Labor

The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Labor, Induced
Drug: recombinant human relaxin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
Not Provided
Not Provided

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
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00259103
RLX.CR.001
Not Provided
Sam Teichman, Chief Medical Officer, BAS Medical
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Not Provided
Study Director: Sam Teichman, MD Chief Medical Officer of BAS Medical, Inc.
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP