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

Corthera

Status and phase: Completed; Phase 2

Conditions: Labor, Induced

Treatments: Drug: Serelaxin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259103

RLX.CR.001

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups

7.5 µg/kg/d

Experimental group

Description:

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

Treatment:

Drug: Serelaxin

25 µg/kg/d

Experimental group

Description:

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

Treatment:

Drug: Serelaxin

75 µg/kg/d

Experimental group

Description:

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

Treatment:

Drug: Serelaxin

Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo