Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ullevaal University Hospital
• Collaborator: Helse Nord
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Misoprostol; Polyestradiol phosphate

Criteria

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