Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

This study has been completed.

Sponsor:

Collaborator:

Helse Nord

Information provided by:

Ullevaal University Hospital

ClinicalTrials.gov Identifier:

NCT00572819

First received: December 12, 2007

Last updated: May 22, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 12, 2007

Last Updated Date

May 22, 2009

Start Date ^ICMJE

January 2008

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00572819 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Difference between baseline cervical dilatation at recruitment and preoperative dilatation. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Women with cervical dilatation ≥ 5 mm. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Acceptability. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Number of dilatations judged as "difficult." [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Frequency of complications. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Difference between baseline cervical dilatation at recruitment and preoperative dilatation. Women with cervical dilatation ≥ 5 mm. Acceptability. Number of dilatations judged as "difficult". Frequency of complications. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Cervical Ripening

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Misoprostol
Intervention: Drug: Misoprostol
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

100

Completion Date

May 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT00572819

Other Study ID Numbers ^ICMJE

2007-004083-52, 2007-004083-52

Has Data Monitoring Committee

Yes

Responsible Party

Britt-Ingjerd Nesheim, Gynaecological Department, Ullevål University Hospital, Oslo, Norway

Study Sponsor ^ICMJE

Ullevaal University Hospital

Collaborators ^ICMJE

Helse Nord

Investigators ^ICMJE

Study Chair:

Britt-Ingjerd Nesheim, MD, PhD

University of Oslo, Faculty of Medicine

Information Provided By

Ullevaal University Hospital

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top