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Oral Misoprostol Before Endometrial Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00200226
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 21, 2007
Sponsor:
Information provided by:
Memorial University of Newfoundland

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date September 21, 2007
Study Start Date  ICMJE February 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2007)		 pain/discomfort of endometrial biopsy [ Time Frame: during procedure ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)		 pain/discomfort of endometrial biopsy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2007)
  • ease of performing biopsy [ Time Frame: during procedure ]
  • success of obtaining biopsy [ Time Frame: during procedure ]
  • potential side effects [ Time Frame: time study drug taken until procedure ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • ease of performing biopsy
  • success of obtaining biopsy
  • potential side effects
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Misoprostol Before Endometrial Biopsy
Official Title  ICMJE Oral Misoprostol Before Endometrial Biopsy
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Endometrial Biopsy
Intervention  ICMJE
  • Drug: misoprostol
    misoprostol 400mcg 12 hrs prior to procedure
    Other Name: Cytotec
  • Drug: vitamin B6
    Vitamin B6 50 mg orally 12 hrs prior to procedure
Study Arms  ICMJE
  • Placebo Comparator: 1
    Vitamin B6
    Intervention: Drug: vitamin B6
  • Active Comparator: 2
    misoprostol
    Intervention: Drug: misoprostol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2007)		 72
Original Enrollment  ICMJE
 (submitted: September 12, 2005)		 104
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00200226
Other Study ID Numbers  ICMJE HIC02.159
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Memorial University of Newfoundland
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joan MG Crane, MD Faculty, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland
PRS Account Memorial University of Newfoundland
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP