The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates

NCT02449161 | Terminated Phase 3

• 1 other identifier: MP-31-2015-998
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Menorrhagia

Keywords

endometrial ablation

Outcome Measures

Primary Outcomes (1)

• quantification of amenorrhea

  using the "Pictorial Blood Loss Assessment Chart" for quantification

  12 months

Secondary Outcomes (2)

• quantification of amenorrhea

  4 months

• documentation of side effects

  4 months

Study Arms (2)

MPA

EXPERIMENTAL

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

Drug: MPA

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

MPA DRUG

Also known as: provera

MPA

placebo DRUG

placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy Waddell: lead
• CSSS Chicoutimi: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Menorrhagia

Interventions

Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 20, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

CA (1)