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

Primary Purpose

Menorrhagia

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
MPA
placebo
Sponsored by
Guy Waddell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring endometrial ablation

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de Sherbrooke

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MPA

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

quantification of amenorrhea
using the "Pictorial Blood Loss Assessment Chart" for quantification

Secondary Outcome Measures

quantification of amenorrhea
using the "Pictorial Blood Loss Assessment Chart" for quantification
documentation of side effects

Full Information

First Posted
May 13, 2015
Last Updated
May 16, 2022
Sponsor
Guy Waddell
Collaborators
CSSS Chicoutimi
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1. Study Identification

Unique Protocol Identification Number
NCT02449161
Brief Title
The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates
Acronym
MPA postAE
Official Title
The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates: a RCT
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Missing fund to continue
Study Start Date
August 2015 (Actual)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guy Waddell
Collaborators
CSSS Chicoutimi

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
endometrial ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MPA
Arm Type
Experimental
Arm Description
medroxyprogesterone acetate, 10 mg/day, for 90 days, following endometrial ablation
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
1 placebo/day, for 90 days, following endometrial ablation
Intervention Type
Drug
Intervention Name(s)
MPA
Other Intervention Name(s)
provera
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
quantification of amenorrhea
Description
using the "Pictorial Blood Loss Assessment Chart" for quantification
Time Frame
12 months
Secondary Outcome Measure Information:
Title
quantification of amenorrhea
Description
using the "Pictorial Blood Loss Assessment Chart" for quantification
Time Frame
4 months
Title
documentation of side effects
Time Frame
4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

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The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates

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