Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

Cervical Ripening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572819
• Other study ID #: 2007-004083-52
• Secondary ID: 2007-004083-52
• Status: Completed
• Phase: Phase 3
• First received: December 12, 2007
• Last updated: May 22, 2009
• Start date: January 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Ullevaal University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Ripening

Intervention

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

Locations

Country	Name	City	State
Norway	Gynaecological Department, Ullevål University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Ullevaal University Hospital	Helse Nord

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups.		24 hours
Secondary	Difference between baseline cervical dilatation at recruitment and preoperative dilatation.		14 days
Secondary	Women with cervical dilatation = 5 mm.		14 days
Secondary	Acceptability.		14 days
Secondary	Number of dilatations judged as "difficult."		14 days
Secondary	Frequency of complications.		14 days