NCT00200226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 21, 2007

Status Verified

September 1, 2007

First QC Date

September 12, 2005

Last Update Submit

September 20, 2007

Conditions

Endometrial Biopsy

Keywords

pain/discomfortcervical dilatationside effects

Outcome Measures

Primary Outcomes (1)

  • pain/discomfort of endometrial biopsy

    during procedure

Secondary Outcomes (3)

  • ease of performing biopsy

    during procedure

  • success of obtaining biopsy

    during procedure

  • potential side effects

    time study drug taken until procedure

Study Arms (2)

1

PLACEBO COMPARATOR

Vitamin B6

Drug: vitamin B6

2

ACTIVE COMPARATOR

misoprostol

Drug: misoprostol

Interventions

misoprostolDRUG

misoprostol 400mcg 12 hrs prior to procedure

Also known as: Cytotec
2
vitamin B6DRUG

Vitamin B6 50 mg orally 12 hrs prior to procedure

1

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women 19 years and older
  • planned endometrial biopsy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Women's Health Centre, Eastern Health

St. John's, Newfoundland and Labrador, A1E 5K9, Canada

Location

Obstetrics and Gynecology Associates

Dartmouth, Nova Scotia, B2Y 4W2, Canada

Location

MeSH Terms

Interventions

MisoprostolVitamin B 6

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPicolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Joan MG Crane, MD

    Faculty, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

February 1, 2003

Study Completion

September 1, 2007

Last Updated

September 21, 2007

Record last verified: 2007-09

Locations

CA(2)