MenorrhagiaPhase 3MPA postAENCT02449161
The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates
A Phase 3 study testing MPA in people with Menorrhagia, run by Guy Waddell at 1 site in Canada.
Trial summary
Heavy menstrual bleeding are a common reason for consultation in gynecology and are defined by International Federation of Gynecology and Obstetrics as the perception of menstrual volume increased regardless of the frequency, duration and regularity. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- MPA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to May 2021
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- endometrial ablation planned for eavy menstrual bleeding
- No abnormalities at hysteroscopy
- No evidence of hyperplasia or neoplasia in endometrial biopsy
- Hysterometry of ≤ 10 cm preoperatively
Who cannot join
- Any indication against MPA
- Intrauterine pathology causing heavy bleeding
- hormonal treatment provided during the postoperative period (during the first 4 months)
- preoperative hormonal therapy with a residual postoperative effect
- breastfeeding
- future pregnancy planned
Show all 12Show fewer
- menopausal women
- endometrial ablation antecedent
- Suspected pelvic infection
- known Hematologic Disease
- Taking anticoagulant
- Taking progestin in the 6 months before surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates: a RCT
Heavy menstrual bleeding are a common reason for consultation in gynecology and are defined by International Federation of Gynecology and Obstetrics as the perception of menstrual volume increased regardless of the frequency, duration and regularity. Some studies report that up to 30% of women will suffer from heavy periods during their lifetime. The first line treatment of heavy bleeding is medical. However, a significant proportion of women require surgery. Until the 80s, hysterectomy was one of the only surgical options and often performed as the first line treatment. Since twenty years now the endometrial ablation has become a preferred option for dysfunctional uterine bleeding and avoids hysterectomy in a significant proportion of patients suffering from this type of problem. Endometrial ablation is much less invasive and morbid than hysterectomy, however, many patients do not achieve a complete amenorrhea with endometrial ablation and about 15% may have to require a new intervention, such as hysterectomy, following the persistence of menstrual problems. A Cochrane review published in 2013 showed that the satisfaction rate following endometrial ablation is high at 70-80% and about 35% of women have amenorrhea. The complete destruction of the endometrium is the most important predictor of the success of the procedure. Studies have shown that better results are obtained when the surgery is performed when the endometrium is thin or immediately following menses or following administration of a hormonal agent causes atrophy of the endometrium. One of the agents studied to prepare the endometrium before ablation is medroxyprogesterone acetate (MPA) as injectables (DMPA) and oral. Progestins have an antiproliferative effect on the endometrium. In recent years, numerous studies have examined the use of various agents preoperatively, including MPA and DMPA to facilitate surgery by reducing the thickness of the endometrium. However, few studies have focused on the conditions of the post-operative period to promote the therapeutic response to the intervention. The investigators hypothesis is whether the MPA administered in immediate post-operative would inhibit proliferation of endometrial cells responsible for the persistence of menstruation and optimize the clinical response to endometrial ablation.
- Conditions
- Menorrhagia
- Being tested
- MPA, placebo
- Keywords
- endometrial ablation
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPADrug
Also called provera
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| MPA | Experimental | medroxyprogesterone acetate, 10 mg/day, for 90 days, following endometrial ablation Receives: Drug: MPA |
| placebo | Placebo comparator | 1 placebo/day, for 90 days, following endometrial ablation Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantification of amenorrhea
using the "Pictorial Blood Loss Assessment Chart" for quantification
Measured: 12 months
Secondary outcomes (2)
quantification of amenorrhea
using the "Pictorial Blood Loss Assessment Chart" for quantification
Measured: 4 months
documentation of side effects
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2021
- Study completionMay 2021
Why it stopped: Missing fund to continue
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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy Waddell
- Sponsor type
- University, hospital or other
- Collaborators
- CSSS Chicoutimi
- Responsible party
- Sponsor-investigator, Guy Waddell, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449161
- Sponsor's protocol ID
- MP-31-2015-998
- Acronym
- MPA postAE
- Status last verified
- May 2022
- First submitted
- 13 May 2015
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates: a RCT
- ClinicalTrials.gov ID
- NCT02449161
- Acronym / sponsor ID
- MPA postAE / MP-31-2015-998
- Conditions
- Menorrhagia
- Keywords
- endometrial ablation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Missing fund to continue
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Guy WaddellUniversity, hospital or other
- Collaborators
- CSSS Chicoutimi
- Study start
- Aug 2015 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 20 May 2015 (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.
Heavy menstrual bleeding are a common reason for consultation in gynecology and are defined by International Federation of Gynecology and Obstetrics as the perception of menstrual volume increased regardless of the frequency, duration and regularity. Some studies report that up to 30% of women will suffer from heavy periods during their lifetime. The first line treatment of heavy bleeding is medical. However, a significant proportion of women require surgery. Until the 80s, hysterectomy was one of the only surgical options and often performed as the first line treatment. Since twenty years now the endometrial ablation has become a preferred option for dysfunctional uterine bleeding and avoids hysterectomy in a significant proportion of patients suffering from this type of problem. Endometrial ablation is much less invasive and morbid than hysterectomy, however, many patients do not achieve a complete amenorrhea with endometrial ablation and about 15% may have to require a new intervention, such as hysterectomy, following the persistence of menstrual problems. A Cochrane review published in 2013 showed that the satisfaction rate following endometrial ablation is high at 70-80% and about 35% of women have amenorrhea. The complete destruction of the endometrium is the most important predictor of the success of the procedure. Studies have shown that better results are obtained when the surgery is performed when the endometrium is thin or immediately following menses or following administration of a hormonal agent causes atrophy of the endometrium. One of the agents studied to prepare the endometrium before ablation is medroxyprogesterone acetate (MPA) as injectables (DMPA) and oral. Progestins have an antiproliferative effect on the endometrium. In recent years, numerous studies have examined the use of various agents preoperatively, including MPA and DMPA to facilitate surgery by reducing the thickness of the endometrium. However, few studies have focused on the conditions of the post-operative period to promote the therapeutic response to the intervention. The investigators hypothesis is whether the MPA administered in immediate post-operative would inhibit proliferation of endometrial cells responsible for the persistence of menstruation and optimize the clinical response to endometrial ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPA | Experimental | Drug: MPAmedroxyprogesterone acetate, 10 mg/day, for 90 days, following endometrial ablation |
| placebo | Placebo comparator | Drug: placebo1 placebo/day, for 90 days, following endometrial ablation |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- endometrial ablation planned for eavy menstrual bleeding
- No abnormalities at hysteroscopy
- No evidence of hyperplasia or neoplasia in endometrial biopsy
- Hysterometry of ≤ 10 cm preoperatively
Key exclusion criteria (12 listed)
- Any indication against MPA
- Intrauterine pathology causing heavy bleeding
- hormonal treatment provided during the postoperative period (during the first 4 months)
- preoperative hormonal therapy with a residual postoperative effect
- breastfeeding
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 |
|---|---|---|
| MPAAlso: provera | Drug | MPA |
| placebo | Drug | placebo |
Primary outcome
quantification of amenorrhea
Time frame: 12 months
using the "Pictorial Blood Loss Assessment Chart" for quantification
2 secondary outcomes
quantification of amenorrhea
Time frame: 4 months
documentation of side effects
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Missing fund to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 MPA in people with Menorrhagia, run by Guy Waddell 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 23 May 2022. 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 stopped early (reason given: Missing fund to continue). Results are not available in the source record.
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?
quantification of amenorrhea (time frame: 12 months). 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 23 May 2022.