Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

Study Overview
=================
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.

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

Conditions
-----------------
Cervical Ripening

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hysteroscopy, Misoprostol, Postmenopausal women, Cervical ripening, Dilatation, Sequential trial, Estradiol