Oral Misoprostol Before Endometrial Biopsy

Memorial University of Newfoundland

Status and phase: Completed; Phase 3

Conditions: Endometrial Biopsy

Treatments: Drug: vitamin B6; Drug: misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00200226

HIC02.159

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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72 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Vitamin B6

Treatment:

Drug: vitamin B6

2

Active Comparator group

Description:

misoprostol

Treatment:

Drug: misoprostol