Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

Phase 3

Completed

• Conditions: Cervical Ripening
• Interventions: Drug: Placebo; Drug: Misoprostol

• Registration Number: NCT00572819
• Lead Sponsor: Ullevaal University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Study Start: 2008-01
• Status Verified: 2009-05
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Last Update Submitted: 2009-05-22
• Last Update Posted: 2009-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Misoprostol	Misoprostol	-

Primary Outcome Measures

Name	Time	Method
The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups.	24 hours

Secondary Outcome Measures

Name	Time	Method
Difference between baseline cervical dilatation at recruitment and preoperative dilatation.	14 days
Women with cervical dilatation ≥ 5 mm.	14 days
Acceptability.	14 days
Number of dilatations judged as "difficult."	14 days
Frequency of complications.	14 days

Trial Locations

Locations (1)

Gynaecological Department, Ullevål University Hospital; 🇳🇴 Oslo, Norway