Oral Misoprostol Before Endometrial Biopsy | NCT00200226

Studies
Oral Misoprostol Before Endometrial Biopsy

NCT00200226

Sponsor

Memorial University of Newfoundland

Status

Completed

Last Update Posted

Sep 21, 2007Estimated

Enrollment

72Actual

Phase

Phase 3

Conditions

Endometrial Biopsy

Interventions

misoprostol
vitamin B6

Countries

Canada

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

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

Feb 2003

Primary Completion Date

Not provided

Completion Date

Sep 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

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

Sep 20, 2007

Last Update Posted Date

Sep 21, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

An endometrial biopsy involves a thin tube being passed through the cervix (opening of the uterus) to obtain a sample of the lining of the uterus. Sometimes there may be discomfort with this procedure especially if the cervix is not dilated or opened. Previous research has suggested that taking a drug called misoprostol may help the cervix to start to dilate or open. This study will see if misoprostol will help open the cervix for an endometrial biopsy, to lessen the discomfort and make the biopsy easier to perform.

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

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Vitamin B6	Drug: vitamin B6
2	Active Comparator	misoprostol	Drug: misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
misoprostol	Drug	misoprostol 400mcg 12 hrs prior to procedure	2	Cytotec

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain/discomfort of endometrial biopsy		during procedure

Secondary Outcomes

Measure	Description	Time Frame
ease of performing biopsy		during procedure
success of obtaining biopsy		during procedure
potential side effects

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women 19 years and older
planned endometrial biopsy

Exclusion Criteria:

known hypersensitivity or allery to prostaglandins
seizure disorder
liver disease
known abnormal liver function tests
pregnancy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 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
Joan MG Crane, MD	Faculty, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's Health Centre, Eastern Health		St. John's	Newfoundland and Labrador	A1E 5K9	Canada
Obstetrics and Gynecology Associates

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol
D025101	Vitamin B 6

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided