At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 124 enrolled

Drug / intervention

Misoprostol vaginal insert 25 mcg +3 moredrug

Likely dose

Misoprostol vaginal insert 25 mcgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00346840

NCT00346840Phase 2Completed

Compare CT.gov

Controlled-Release Misoprostol Vaginal Insert in Parous Women for Labor Induction: Randomized Trial

Ferring Pharmaceuticals·interventional·Posted Jun 30, 2006·Updated Jun 18, 2012

In Brief

A Phase 2 clinical trial evaluating Misoprostol vaginal insert 25 mcg, Misoprostol vaginal insert 50 mcg, and 2 other interventions for Labor Induction and Cervical Ripening. Completed, enrolled 124 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLabor Induction, Cervical Ripening

CountriesUnited Kingdom

Collaborators--

Timeline

Phase 2CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2003

Primary CompletionFeb 2004

Study CompletionMar 2004

First PostedJun 2006

TodayJul 2026

First PostedJun 30, 2006

Enrollment StartJun 1, 2003

Primary CompletionFeb 1, 2004

Study CompletionMar 1, 2004

TodayJul 2, 2026

Enrollment to primary: 8 monthsPosted 20.0 years ago

Interventions

Misoprostol vaginal insert 25 mcgdrug

One hydrogel polymer vaginal insert for up to 24h

Misoprostol vaginal insert 50 mcgdrug

One hydrogel polymer vaginal insert for up to 24h

Misoprostol vaginal insert 100 mcgdrug

One hydrogel polymer vaginal insert for up to 24h

Misoprostol vaginal insert 200 mcgdrug

One hydrogel polymer vaginal insert for up to 24h