Trial | NCT00259103  Report issue

Title

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 Labour

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    serelaxin ...

  • Study Participants

    72
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.
Study Started
Nov 30
2005
Primary Completion
Oct 31
2006
Study Completion
Oct 31
2006
Last Update
May 07
2014
Estimate

Drug Serelaxin

Drug Placebo

7.5 µg/kg/d Experimental

Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A.

25 µg/kg/d Experimental

Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A.

75 µg/kg/d Experimental

Participants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B.

Placebo Experimental

Participants who received IV infusion of placebo, some during part A and others during part B.

Criteria 

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
No Results Posted