Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

July 31, 2011

Study Completion Date

July 31, 2011

Conditions
Cervical RipeningInduction of Labor
Interventions
DRUG

MVI 200

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.

Trial Locations (1)

91105

Huntington Memorial Hospital, Pasadena

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY