Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

Sponsor

Ullevaal University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00572819

Collaborator

Helse Nord (Industry)

100

Enrollment

Location

Arms

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Ripening	Drug: Misoprostol Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Does Self-Administered Vaginal Misoprostol Result in Cervical Ripening in Postmenopausal Women After 14 Days Pre-Treatment With Estradiol?

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Misoprostol	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.
Placebo Comparator: Placebo	Drug: Placebo Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.

Arm

Intervention/Treatment

Active Comparator: Misoprostol

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.

Placebo Comparator: Placebo

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups. [24 hours]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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