Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: Mifepristone; Drug: PLACEBO

• Registration Number: NCT02271958
• Lead Sponsor: Mediterranea Medica S. L.

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of 2.5, 5 and 10 mg doses of mifepristone against a placebo in women with laparoscopic diagnostic of endometriosis.

The hypothesis of the study is that the 5 mg mifepristone dose is safe and effective and should be used in future studies on medical treatment of endometriosis.

Detailed Description

This is double-blind randomized clinical trial.

Examinations undertaken Thorough gynecological examination, pelvic ultrasound examination, diagnostic laparoscopy before starting treatment in order to determine the localization, extent and degree of severity of the endometrial lesions and a score was assigned in accordance with the revised American Fertility Society (AFS) classification.19 Blood samples were taken for hematological tests and hepatic function. Endometrial biopsy was performed if endometrial thickness as calibrated by ultrasound was \>8 mm or if there had been abnormal bleeding in the past 3 months. After 90 and 180 days of treatment an ultrasound examination of the pelvis was carried out and then followed by diagnostic-therapeutic laparoscopy and endometrial biopsy.

Subjects Women with laparoscopic confirmed diagnosis of endometriosis who volunteered to take part in the study. Inclusion criteria: a) age between 18 and 45, b) certain diagnosis of endometriosis of any degree corresponding to the American Fertility Society (AFS); c) patients with symptoms of endometriosis: dysmenorrhea or pelvic pain not attributable to other gynecological illness and d) acceptance of the use of barrier contraceptive methods during the study. Exclusion criteria: a) breastfeeding, b) hormonal or surgical treatment for the endometriosis less than 4 months previous to study, c) diabetes, d) severe arterial hypertension, e) hepatopathy, f) renal malfunction, g) endocrinopathy, and f) any other contraindication regarding the use of antiprogestins.

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Study First Submitted: 2014-09-04
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-20
• Last Update Submitted: 2014-10-20
• Study First Posted: 2014-10-22
• Last Update Posted: 2014-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

• Women with laparoscopic confirmed diagnosis of endometriosis
• Age between 18 and 45
• Certain diagnosis of endometriosis of any degree corresponding to the American Fertility Society (AFS)
• Patients with symptoms of endometriosis: dysmenorrhea or pelvic pain not attributable to other gynecological illness and
• Acceptance of the use of barrier contraceptive methods during the study

Exclusion Criteria

• Breastfeeding
• Hormonal or surgical treatment for the endometriosis less than 4 months previous to study
• Diabetes
• Severe arterial hypertension
• Hepatopathy
• Renal malfunction
• Endocrinopathy
• Any other contraindication regarding the use of antiprogestins.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Mifepristone	Oral administration of 2,5 mg of mifepristone daily for 6 months
Group 4	PLACEBO	Oral administration of mifepristone placebo daily for 3 months
Group 2	Mifepristone	Oral administration of 5 mg of mifepristone daily for 6 months
Group 3	Mifepristone	Oral administration of 10 mg of mifepristone daily for 6 months

Primary Outcome Measures

Name	Time	Method
Changes in prevalence of dysmenorrhea and the average reduction in its intensity.	6 months	The principal variables in evaluating effectiveness were the percentage changes in prevalence of dysmenorrhea and the average reduction in its intensity.
Changes in scores according to American Fertility Society (AFS)	6 months	Effectiveness was assessed by measuring changes in scores according to American Fertility Society (AFS)
Incidence of hot flushes, nausea, dizzy spells, vomiting, fatigue/tiredness, raised hepatic transaminases, histological alterations of the endometrium.	6 months	Safety was evaluated by the incidence of hot flushes, nausea, dizzy spells, vomiting, fatigue/tiredness, raised hepatic transaminases, histological alterations of the endometrium.

Trial Locations

Locations (1)

Hospital Eusebio Hernández, "Maternidad Obrera"; 🇨🇺 Havana, Cuba