Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Ripening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Misoprostol

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.

Interventions

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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.

Intervention Type DRUG

Placebo

Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No