NCT00528255

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

A Multicenter, Open-Label, Phase II Study of the Pharmacokinetics and Safety of the100 Mcg Misoprostol Vaginal Insert (MVI 100) in Women Requiring Cervical Ripening and Induction of Labor

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

PK study in women requiring cervical ripening.

Conditions

• Cervical Ripening
• Induction of Labor

Interventions

Type	Name	Description
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.

Timeline

• First posted: 2007-09-12
• Last updated: 2012-06-18

Locations

6 sites across 1 country: United States