Evaluation of the Safety of Relaxin in Preeclampsia

A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Recombinant Human Relaxin (rhRlx) in Subjects With Preeclampsia

Status

Suspended

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00333307

Enrollment

Registered

2006-06-05

Start date

2006-10-31

Completion date

Unknown

Last updated

2010-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Eclampsia

Keywords

relaxin, preeclampsia

Brief summary

The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia

Detailed description

The effects of relaxin may be beneficial in the treatment of women with preeclampsia. This study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women with severe preeclampsia.

Interventions

DRUGrecombinant human relaxin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of preeclampsia * Hospital admission for expectant management

Exclusion criteria

* Eclampsia or history of seizures * Vaginal bleeding * Multifetal gestation * Requirement for immediate delivery

Design outcomes

Primary

Measure	Time frame
maternal adverse experiences	—
fetal adverse experiences	—
neonatal adverse experiences	—

Secondary

Measure	Time frame
preeclampsia assessments	—
clinical laboratory assessments	—
vital signs	—
physical examinations	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026