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Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)

NCT00528255 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-06-18

No results posted yet for this study

Summary

This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal insert when administered to nulliparous women at term gestation requiring cervical ripening and induction of labor.

Conditions

  • Cervical Ripening
  • Induction of Labor

Interventions

DRUG

Misoprostol Vaginal Insert (MVI 100)

The MVI 100 is misoprostol 100 mcg, formulated in a sustained release, nonbiodegradeable hydrogel polymer, with a polyester knit retrieval tape; IV oxytocin is permitted ad lib 30 minutes following removal of the MVI assuming no contraindications.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Steven Wininger, MD · Precision Trials

  • Arlen Jarrett, MD · South Valley Women's Research

  • Deborah Wing, MD · UCI Medical Center/Long Beach Memorial Hospital

  • Raymond Brown, MD · Temple University Hospital

  • James Byrne, MD · Santa Clara Valley Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • United States

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 NCT00528255 on ClinicalTrials.gov