Efficacy and Safety Study of the Misoprostol Vaginal Priming Insert (MVPI) Prior to Hysteroscopy

PHASE2CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Cervical Priming
Interventions
DRUG

misoprostol

One vaginal insert containing 100, 200, 400, 800, 1200, 1600 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure. An adaptive design will be used to determine whether to escalate or reduce the dose, starting with MVPI 400 mcg.

DRUG

placebo

placebo

Trial Locations (2)

27103

Lyndhurst Gynecologic Associates, Winston-Salem

85032

Precision Trials, Phoenix

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY