The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates: a RCT

Conditions
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Menorrhagia

Intervention / Treatment
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* Drug: MPA
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPA<br>medroxyprogesterone acetate, 10 mg/day, for 90 days, following endometrial ablation | Drug: MPA<br> <br> * Other names: provera;|
| Placebo Comparator: placebo<br>1 placebo/day, for 90 days, following endometrial ablation | Drug: placebo<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial ablation