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

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.

Study Overview

• Status: Terminated
• Conditions: Menorrhagia
• Intervention / Treatment: Drug: placebo; Drug: MPA

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quantification of amenorrhea	using the "Pictorial Blood Loss Assessment Chart" for quantification	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quantification of amenorrhea	using the "Pictorial Blood Loss Assessment Chart" for quantification	4 months
documentation of side effects		4 months

Collaborators and Investigators

• Sponsor: Guy Waddell
• Collaborators: CSSS Chicoutimi

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 20, 2015

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: endometrial ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Amenorrhea; Menorrhagia; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents, Male; Medroxyprogesterone Acetate
• Other Study ID Numbers: MP-31-2015-998