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MPA postAE: The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates

Sponsor
Guy Waddell (Other)
Overall Status
Terminated
CT.gov ID
NCT02449161
Collaborator
CSSS Chicoutimi (Other)
60
Enrollment
1
Location
2
Arms
69
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates: a RCT
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: MPA

medroxyprogesterone acetate, 10 mg/day, for 90 days, following endometrial ablation

Drug: MPA
Other Names:
  • provera

    		•
    Placebo Comparator: placebo

    1 placebo/day, for 90 days, following endometrial ablation

    Drug: placebo

    Outcome Measures

    Primary Outcome Measures

    1. quantification of amenorrhea [12 months]

      using the "Pictorial Blood Loss Assessment Chart" for quantification

    Secondary Outcome Measures

    1. quantification of amenorrhea [4 months]

      using the "Pictorial Blood Loss Assessment Chart" for quantification

    2. documentation of side effects [4 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    • menopausal women

    • endometrial ablation antecedent

    • Suspected pelvic infection

    • known Hematologic Disease

    • Taking anticoagulant

    • Taking progestin in the 6 months before surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec Canada J1H 5N4

    Sponsors and Collaborators

    • Guy Waddell
    • CSSS Chicoutimi

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guy Waddell, MD, Université de Sherbrooke
    ClinicalTrials.gov Identifier:
    NCT02449161
    Other Study ID Numbers:
    • MP-31-2015-998
    First Posted:
    May 20, 2015
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Guy Waddell, MD, Université de Sherbrooke
    endometrial ablation
    Additional relevant MeSH terms:
    Menorrhagia
    Amenorrhea
    Medroxyprogesterone Acetate

    Study Results

    No Results Posted as of May 23, 2022