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...
Brief Summary
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 Labor”
The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial 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 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.
Intervention(s) in this Clinical Trial
- Drug: recombinant human relaxin
Outcome Measures for this Clinical Trial
Primary Measures
- Cervical ripening
Secondary Measures
- Progression to active labor and delivery
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 40 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Corthera, Inc. Industry
Overall Clinical Trial Officials and Contacts
Sam Teichman, MD Study Director Chief Medical Officer of BAS Medical, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00259103
Study ID Number: RLX.CR.001
ClinicalTrials.gov Identifier: NCT00259103
Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00259103
