CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,308 enrolled
Drug / intervention
Misoprostol vaginal insert 100 mcg +2 moredrug
Likely dose
Misoprostol vaginal insert 100 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/NCT00308711
NCT00308711Phase 3Completed
CompareCT.gov

A Multi-center, Randomized, Double-blind Phase III Study of the Efficacy and Safety of the Misoprostol Vaginal Insert Compared to Cervidil for Women Requiring Cervical Ripening and Induction of Labor (The MVP Study).

Ferring Pharmaceuticals·interventional·Posted Mar 30, 2006·Updated Jun 25, 2012

In Brief

A Phase 3 clinical trial evaluating Misoprostol vaginal insert 100 mcg, Misoprostol vaginal insert 50 mcg, and 1 other intervention for Cervical Ripening and Labor, Induced. Completed, enrolled 1,308 participants across 52 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Ripening, Labor, Induced
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 30, 2006
Enrollment StartApr 1, 2006
Primary CompletionAug 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.3 years ago

Interventions

Misoprostol vaginal insert 100 mcgdrug

Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.

Misoprostol vaginal insert 50 mcgdrug

Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.

Dinoprostone vaginal insert (Cervidil)drug

Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.