At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 24 enrolled

Drug / intervention

MVI 200drug

Likely dose

MVI 200 200 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/NCT01283022

NCT01283022Phase 2Completed

Compare CT.gov

A Multicenter, Open-Label, Phase II Study of the 200 mcg Misoprostol Vaginal Insert (MVI 200) to Obtain Pharmacokinetics in Women at Term Gestation (The MVI-PK Study)

Ferring Pharmaceuticals·interventional·Posted Jan 25, 2011·Updated Apr 14, 2014

In Brief

A Phase 2 clinical trial evaluating MVI 200 for Cervical Ripening and Induction of Labor. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for the MVI 200 in women requiring cervical ripening and induction of labor.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCervical Ripening, Induction of Labor

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

First PostedJan 2011

Enrollment StartMay 2011

Primary CompletionJul 2011

TodayJul 2026

First PostedJan 25, 2011

Enrollment StartMay 1, 2011

Primary CompletionJul 1, 2011

TodayJul 2, 2026

Enrollment to primary: 2 monthsPosted 15.4 years ago

Interventions

MVI 200drug

Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.