MenorrhagiaPhase 3NCT00953641
Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
A Phase 3 study testing Misoprostol in people with Menorrhagia and Endometrial Biopsy, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether using Misoprostol vaginally before an office endometrial biopsy is performed, will make it easier, more successful and less painful to do the procedure. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Menorrhagia, Endometrial Biopsy, Cervical Ripening
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Sep 2012
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with abnormal uterine bleeding
- Age over 35 years
Who cannot join
- Pregnancy
- Allergy to or contraindication to prostaglandin use
- Active genital tract infections
- Bleeding disorders
Trial locations and contacts
1 site in 1 country.
Canada1 site
Obstetrics and Gynecologic Consultants
Saskatoon, Saskatchewan, S7K 1N8
About this study
The purpose of this study is to determine whether using Misoprostol vaginally before an office endometrial biopsy is performed, will make it easier, more successful and less painful to do the procedure.
The investigators' hypothesis is that vaginal Misoprostol 12 hours prior to endometrial biopsy will increase the ease of performing office endometrial biopsy by reducing the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle.
Read the detailed description
Endometrial biopsy is a common gynecological office procedure performed to assist in the pathological diagnosis of abnormal vaginal bleeding. The procedure can be painful and it may be difficult to obtain an endometrial sample with a hard and closed cervix. Giving Misoprostol before the procedure may soften the cervix sufficiently to allow an easier and more successful test. This medication has been tested before hysteroscopy and in some patients it has been shown to be beneficial.
104 patients need to be recruited for this study. Participants will be divided according to pre-menopausal and post-menopausal status. Each of these groups will then be divided into a treatment arm (with Misoprostol) and a placebo arm. Participants will place a vaginal suppository containing either Misoprostol 400 ug or a placebo 12h or more before their appointment for the endometrial biopsy.
- Conditions
- Menorrhagia, Endometrial Biopsy, Cervical Ripening
- Being tested
- Misoprostol, Placebo
- Keywords
- Vaginal Misoprostol, Cervical ripening, Endometrial biopsy
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure
PlaceboDrug
Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy
| Study group | Role | What they receive |
|---|---|---|
| Pre-Menopausal 1 | Active comparator | Pre-Menopausal group, receiving Misoprostol Receives: Drug: Misoprostol |
| Pre-Menopausal 2 | Placebo comparator | Patients will insert a placebo vaginal suppository 12h or more prior to the endometrial biopsy Receives: Drug: Placebo |
| Post-Menopausal 1 | Active comparator | Post-Menopausal patients will insert a Misoprostol vaginal suppository 12h or more prior to the endometrial biopsy Receives: Drug: Misoprostol |
| Post-Menopausal 2 | Placebo comparator | Placebo vaginal suppository prior to the endometrial biopsy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the ease of an endometrial biopsy by the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle
Measured: 1 year
Secondary outcomes (4)
Evaluating participants discomfort during the procedure, using a pain scale
Measured: 1 year
Success rate of passage of the pipelle
Measured: 1 year
Adverse effects from medications
Measured: 1 year
Complications of the procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startSep 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Why it stopped: Principle Investigator retired, Resident moved away
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Harding, University of Saskatchewan
- Investigators
- Roger Pierson, PhD, Study chair, University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of MedicineAnita Harding, MBChB, Principal investigator, University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of MedicineThirza Smith, MD, FRCS, Principal investigator, University of Saskatchewan, Dept. of Obstetrics and GynecologyMarilyn Davidson, FRCSC, Principal investigator, University of Saskatchewan, Dept. of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953641
- Sponsor's protocol ID
- 07-134
- Status last verified
- Aug 2012
- First submitted
- 26 Aug 2008
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
- ClinicalTrials.gov ID
- NCT00953641
- Acronym / sponsor ID
- 07-134
- Conditions
- Menorrhagia, Endometrial Biopsy, Cervical Ripening
- Keywords
- Vaginal Misoprostol, Cervical ripening, Endometrial biopsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principle Investigator retired, Resident moved away
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 6 Aug 2009 (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.
The purpose of this study is to determine whether using Misoprostol vaginally before an office endometrial biopsy is performed, will make it easier, more successful and less painful to do the procedure.
The investigators' hypothesis is that vaginal Misoprostol 12 hours prior to endometrial biopsy will increase the ease of performing office endometrial biopsy by reducing the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle.
Detailed description
Endometrial biopsy is a common gynecological office procedure performed to assist in the pathological diagnosis of abnormal vaginal bleeding. The procedure can be painful and it may be difficult to obtain an endometrial sample with a hard and closed cervix. Giving Misoprostol before the procedure may soften the cervix sufficiently to allow an easier and more successful test. This medication has been tested before hysteroscopy and in some patients it has been shown to be beneficial.
104 patients need to be recruited for this study. Participants will be divided according to pre-menopausal and post-menopausal status. Each of these groups will then be divided into a treatment arm (with Misoprostol) and a placebo arm. Participants will place a vaginal suppository containing either Misoprostol 400 ug or a placebo 12h or more before their appointment for the endometrial biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pre-Menopausal 1 | Active comparator | Drug: MisoprostolPre-Menopausal group, receiving Misoprostol |
| Pre-Menopausal 2 | Placebo comparator | Drug: PlaceboPatients will insert a placebo vaginal suppository 12h or more prior to the endometrial biopsy |
| Post-Menopausal 1 | Active comparator | Drug: MisoprostolPost-Menopausal patients will insert a Misoprostol vaginal suppository 12h or more prior to the endometrial biopsy |
| Post-Menopausal 2 | Placebo comparator | Drug: PlaceboPlacebo vaginal suppository prior to the endometrial biopsy |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with abnormal uterine bleeding
- Age over 35 years
Key exclusion criteria (4 listed)
- Pregnancy
- Allergy to or contraindication to prostaglandin use
- Active genital tract infections
- Bleeding disorders
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 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure | Drug | Post-Menopausal 1, Pre-Menopausal 1 |
| PlaceboWitepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy | Drug | Post-Menopausal 2, Pre-Menopausal 2 |
Primary outcome
Evaluating the ease of an endometrial biopsy by the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle
Time frame: 1 year
4 secondary outcomes
Evaluating participants discomfort during the procedure, using a pain scale
Time frame: 1 year
Success rate of passage of the pipelle
Time frame: 1 year
Adverse effects from medications
Time frame: 1 year
Complications of the procedure
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
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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.
Roger Pierson, PhD study chair
University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine
Anita Harding, MBChB principal investigator
University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine
Thirza Smith, MD, FRCS principal investigator
University of Saskatchewan, Dept. of Obstetrics and Gynecology
1 site 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 in people with Menorrhagia and Endometrial Biopsy, run by University of Saskatchewan at 1 site 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 4 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: withdrawn, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluating the ease of an endometrial biopsy by the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle (time frame: 1 year). 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 14 Aug 2012; AzTrials last refreshed its copy on 7 Nov 2026.