Endometrial BiopsyPhase 3NCT00200226
Oral Misoprostol Before Endometrial Biopsy
A Phase 3 study testing misoprostol and vitamin B6 in people with Endometrial Biopsy, run by Memorial University of Newfoundland at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Biopsy
- What is being tested?
- misoprostol and vitamin B6
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2003to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women 19 years and older
- planned endometrial biopsy
Who cannot join
- known hypersensitivity or allery to prostaglandins
- seizure disorder
- liver disease
- known abnormal liver function tests
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Obstetrics and Gynecology Associates
Dartmouth, Nova Scotia, B2Y 4W2
Women's Health Centre, Eastern Health
St. John's, Newfoundland and Labrador, A1E 5K9
About this study
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.
- Conditions
- Endometrial Biopsy
- Being tested
- misoprostol, vitamin B6
- Keywords
- pain/discomfort, cervical dilatation, side effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostolDrug
Also called Cytotec
misoprostol 400mcg 12 hrs prior to procedure
vitamin B6Drug
Vitamin B6 50 mg orally 12 hrs prior to procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Vitamin B6 Receives: Drug: vitamin B6 |
| 2 | Active comparator | misoprostol Receives: Drug: misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain/discomfort of endometrial biopsy
Measured: during procedure
Secondary outcomes (3)
ease of performing biopsy
Measured: during procedure
success of obtaining biopsy
Measured: during procedure
potential side effects
Measured: time study drug taken until procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Investigators
- Joan MG Crane, MD, Principal investigator, Faculty, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200226
- Sponsor's protocol ID
- HIC02.159
- Status last verified
- Sep 2007
- First submitted
- 12 Sep 2005
- Last updated
- 21 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Misoprostol Before Endometrial Biopsy
- ClinicalTrials.gov ID
- NCT00200226
- Acronym / sponsor ID
- HIC02.159
- Conditions
- Endometrial Biopsy
- Keywords
- pain/discomfort, cervical dilatation, side effects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- Feb 2003
- Study completion
- Sep 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: vitamin B6Vitamin B6 |
| 2 | Active comparator | Drug: misoprostolmisoprostol |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women 19 years and older
- planned endometrial biopsy
Key exclusion criteria (5 listed)
- known hypersensitivity or allery to prostaglandins
- seizure disorder
- liver disease
- known abnormal liver function tests
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| misoprostolAlso: Cytotecmisoprostol 400mcg 12 hrs prior to procedure | Drug | 2 |
| vitamin B6Vitamin B6 50 mg orally 12 hrs prior to procedure | Drug | 1 |
Primary outcome
pain/discomfort of endometrial biopsy
Time frame: during procedure
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2007.
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Endometrial Biopsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan MG Crane, MD principal investigator
Faculty, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing misoprostol and vitamin B6 in people with Endometrial Biopsy, run by Memorial University of Newfoundland at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain/discomfort of endometrial biopsy (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2007.