Hysteroscopy After Pretreatment With Misoprostol and Estr... | NCT00572819

Studies
Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

NCT00572819

Sponsor

Ullevaal University Hospital

Status

Completed

Last Update Posted

May 25, 2009Estimated

Enrollment

100Estimated

Phase

Phase 3

Conditions

Cervical Ripening

Interventions

Misoprostol
Placebo

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-004083-52

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Dec 12, 2007

First Submission Date that Met QC Criteria

Dec 12, 2007

First Posted Date

Dec 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2009

Last Update Posted Date

May 25, 2009Estimated

Name	Class
Helse Nord	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Misoprostol	Active Comparator		Drug: Misoprostol
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Britt-Ingjerd Nesheim, MD, PhD	University of Oslo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gynaecological Department, Ullevål University Hospital		Oslo		N-0450	Norway

Type	Date	Date Unknown
Release	Jul 27, 2009
Reset	Sep 2, 2009
Release	Sep 21, 2009
Reset	Sep 30, 2009
Release	Dec 2, 2009
Reset	Jan 5, 2010
Release	Jan 8, 2010
Reset	Feb 1, 2010
Release	Jun 30, 2011
Reset	Jul 28, 2011
Release	Aug 17, 2012
Reset	Sep 13, 2012

Submission Tracking

Estimated Results First Submitted Date

Jul 27, 2009

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 27, 2009			Sep 2, 2009
Sep 21, 2009

Condition Browse Module

MeSH Terms

ID	Term
D004108	Dilatation, Pathologic

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol

Ancestor Terms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided