Efficacy and Safety Study of the Misoprostol Vaginal Priming Insert (MVPI) Prior to Hysteroscopy
Condition: Cervical Priming
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      Prior to the hysteroscopy procedure, study staff will record the type of procedure that will
      be conducted and the desired cervical dilatation. The study drug will be removed in the
      office and then a vaginal examination will be performed for signs of irritation or trauma.
      The diameter of the internal os will then be assessed using Hegar dilators. The diameter of
      the internal os will be assessed by the largest size of Hegar dilator that can be inserted
      into the internal os without resistance. If the subject requires further dilatation prior to
      the procedure, this will be noted; additional dilatation is per clinician preference. The use
      of a tenaculum to allow insertion of the dilator(s)/ hysteroscope should be recorded. The
      time of starting and ending the hysteroscopy procedure will be documented. The start time of
      the hysteroscopy procedure is taken from the time of insertion of the first Hegar dilator to
      completion of the hysteroscopy procedure. Cervical priming assessment and safety will be
      recorded.

      The subject will attend the clinic for follow-up assessments 7 days after the procedure.

      Adverse events and concomitant medications will be recorded throughout the study.

      The study will use an adaptive design, beginning with the MVPI 400 mcg and escalating or
      reducing the dose depending on results seen with a particular dose.
    

Intervention name(s): misoprostol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; placebo
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hysteroscopy; Cervical priming; Cervical dilatation; Misoprostol; Endoscopy, uterine