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

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.