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Completed

NCT Number: NCT00259103

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.

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Key information

Conditions

Labor, Induced

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Novosibirsk State Medical Academy, Novosibirsk, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serelaxin

Drug

Placebo

Drug

Primary outcomes

  1. Cervical ripening

    Time frame: Through 24 hours

Secondary outcomes

  1. Progression to active labor and delivery

    Time frame: Within 7 Days of Drug Infusion

Sponsors and collaborators

Lead sponsor

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 29, 2005
Registry last updated
May 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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