Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

Overview

The aim of this study is to investigate whether 1000 micrograms of self-administered vaginal misoprostol 12 hours before operative hysteroscopy results in effective preoperative cervical ripening after two weeks pretreatment with 25 micrograms daily vaginal estradiol, compared to placebo (lactosum monohydricum) in postmenopausal women.

Full Title of Study: “Does Self-Administered Vaginal Misoprostol Result in Cervical Ripening in Postmenopausal Women After 14 Days Pre-Treatment With Estradiol?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: May 2009

Interventions

  • Drug: Misoprostol
    • 1000 micrograms of self-administered vaginal misoprostol compared to placebo 12 hours before operative hysteroscopy after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.
  • Drug: Placebo
    • Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.

Arms, Groups and Cohorts

  • Active Comparator: Misoprostol
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups.
    • Time Frame: 24 hours

Secondary Measures

  • Difference between baseline cervical dilatation at recruitment and preoperative dilatation.
    • Time Frame: 14 days
  • Women with cervical dilatation ≥ 5 mm.
    • Time Frame: 14 days
  • Acceptability.
    • Time Frame: 14 days
  • Number of dilatations judged as “difficult.”
    • Time Frame: 14 days
  • Frequency of complications.
    • Time Frame: 14 days

Participating in This Clinical Trial

Inclusion Criteria

  • All postmenopausal (> one year since last menstruation) women who are referred to outpatient hysteroscopy with a medical indication for hysteroscopy, and who have given informed consent, will be eligible for study recruitment

Exclusion Criteria

  • Women who do not wish to participate
  • Women who are medically unfit for hysteroscopy
  • Women who are medically unfit for participation in any clinical trial
  • Women who do not have a medical indication for hysteroscopy
  • Women who have previously had, or currently have breast or gynaecological cancer
  • Women who have a medical contraindication for locally applied oestradiol
  • Women who are currently using hormone therapy
  • Women who are unable to communicate in Norwegian, and
  • Women with a known allergy to misoprostol

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ullevaal University Hospital
  • Collaborator
    • Helse Nord
  • Provider of Information About this Clinical Study
    • Britt-Ingjerd Nesheim, Gynaecological Department, Ullevål University Hospital, Oslo, Norway
  • Overall Official(s)
    • Britt-Ingjerd Nesheim, MD, PhD, Study Chair, University of Oslo

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