Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

Ullevaal University Hospital

Status and phase: Completed; Phase 3

Conditions: Cervical Ripening

Treatments: Drug: Misoprostol; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00572819

2007-004083-52

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Misoprostol

Active Comparator group

Treatment:

Drug: Misoprostol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo