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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00200226
Other study ID # HIC02.159
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated September 20, 2007
Start date February 2003
Est. completion date September 2007

Study information

Verified date September 2007
Source Memorial University of Newfoundland
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
misoprostol
misoprostol 400mcg 12 hrs prior to procedure
vitamin B6
Vitamin B6 50 mg orally 12 hrs prior to procedure

Locations

Country Name City State
Canada Obstetrics and Gynecology Associates Dartmouth Nova Scotia
Canada Women's Health Centre, Eastern Health St. John's Newfoundland and Labrador

Sponsors (1)

Lead Sponsor Collaborator
Memorial University of Newfoundland

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain/discomfort of endometrial biopsy during procedure
Secondary ease of performing biopsy during procedure
Secondary success of obtaining biopsy during procedure
Secondary potential side effects time study drug taken until procedure
See also
  Status Clinical Trial Phase
Completed NCT01908738 - Effectiveness of Paracervical Block Versus Lidocaine Spray During Endometrial Biopsy N/A
Withdrawn NCT00953641 - Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy Phase 3
Completed NCT02465320 - COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy Phase 2
Recruiting NCT06180317 - The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy N/A
Recruiting NCT01963819 - Therapeutic Endometrial Biopsy N/A