A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to
assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol
Vaginal Priming Insert (MVPI) for Women Requiring Cervical Priming prior to an in-office
hysteroscopy procedure. Each subject will be randomized to receive one vaginal insert. The
study drug will be administered vaginally by a member of the clinical research team (Part I)
or insert herself (Part II) 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.
The internal os of the cervix will be measured at baseline, just prior to the hysteroscopy
and at the follow up visit. The primary outcome measure is change in diameter of the internal
cervical os from baseline (pre-treatment) to just prior to the hysteroscopy procedure
(post-treatment). The hypothesis is that treatment with the MVPI will soften and dilate the
cervix better than placebo.