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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in Canada

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 groups in NCT02449161
Study groupRoleWhat they receive
MPAExperimentalmedroxyprogesterone acetate, 10 mg/day, for 90 days, following endometrial ablation
Receives: Drug: MPA
placeboPlacebo comparator1 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.

  1. quantification of amenorrhea

    using the "Pictorial Blood Loss Assessment Chart" for quantification

    Measured: 12 months

Secondary outcomes (2)
  1. quantification of amenorrhea

    using the "Pictorial Blood Loss Assessment Chart" for quantification

    Measured: 4 months

  2. 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.

  1. First posted20 May 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionMay 2021
  4. Study completionMay 2021

Why it stopped: Missing fund to continue

Resources

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)
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

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.

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