Oral Misoprostol Before Endometrial Biopsy

• Sponsor: Memorial University of Newfoundland (Other)
• Overall Status: Completed
• CT.gov ID: NCT00200226
• Collaborator: (none)
• Enrollment: 72
• Locations: 2
• Arms: 2
• Duration (Months): 55
• Patients Per Site: 36
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Biopsy	Drug: misoprostol; Drug: vitamin B6	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Oral Misoprostol Before Endometrial Biopsy
• Study Start Date: Feb 1, 2003
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Vitamin B6	Drug: vitamin B6; Vitamin B6 50 mg orally 12 hrs prior to procedure
Active Comparator: 2 misoprostol	Drug: misoprostol; misoprostol 400mcg 12 hrs prior to procedure; Other Names: Cytotec

Outcome Measures

Primary Outcome Measures

1. pain/discomfort of endometrial biopsy [during procedure]

Secondary Outcome Measures

1. ease of performing biopsy [during procedure]

2. success of obtaining biopsy [during procedure]

3. potential side effects [time study drug taken until procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Health Centre, Eastern Health	St. John's	Newfoundland and Labrador	Canada	A1E 5K9
2	Obstetrics and Gynecology Associates	Dartmouth	Nova Scotia	Canada	B2Y 4W2

Sponsors and Collaborators

• Memorial University of Newfoundland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00200226
• Other Study ID Numbers: HIC02.159
• First Posted: Sep 20, 2005
• Last Update Posted: Sep 21, 2007
• Last Verified: Sep 1, 2007

• Keywords provided by , ,: pain/discomfort; cervical dilatation; side effects
• Additional relevant MeSH terms: Vitamin B 6; Pyridoxal; Pyridoxine; Misoprostol

Study Results

No Results Posted as of Sep 21, 2007