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Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour

NCT00346840 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2012-06-18

No results posted yet for this study

Summary

The primary objective of the study was assessment of the efficacy of four dose reservoirs (25 mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered for up to 24 hours. Efficacy was measured in terms of time from insert placement to vaginal delivery.

Conditions

  • Labor Induction
  • Cervical Ripening

Interventions

DRUG

Misoprostol vaginal insert 25 mcg

One hydrogel polymer vaginal insert for up to 24h

DRUG

Misoprostol vaginal insert 50 mcg

One hydrogel polymer vaginal insert for up to 24h

DRUG

Misoprostol vaginal insert 100 mcg

One hydrogel polymer vaginal insert for up to 24h

DRUG

Misoprostol vaginal insert 200 mcg

One hydrogel polymer vaginal insert for up to 24h

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Helen Colquhoun, MD · Pleiad, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2004-02-29
Completion
2004-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00346840 on ClinicalTrials.gov