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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Mifepristone
* Drug: PLACEBO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Group 1<br>Oral administration of 2,5 mg of mifepristone daily for 6 months | Drug: Mifepristone<br> <br> |
| Experimental: Group 2<br>Oral administration of 5 mg of mifepristone daily for 6 months | Drug: Mifepristone<br> <br> |
| Experimental: Group 3<br>Oral administration of 10 mg of mifepristone daily for 6 months | Drug: Mifepristone<br> <br> |
| Experimental: Group 4<br>Oral administration of mifepristone placebo daily for 3 months | Drug: PLACEBO<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mifepristone, Endometriosis