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

Mediterranea Medica S. L.

Status and phase: Completed; Phase 3; Phase 2

Conditions: Endometriosis

Treatments: Drug: Mifepristone; Drug: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT02271958

Endomife 2,5/5/10/placebo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 4 patient groups

Group 1

Experimental group

Description:

Oral administration of 2,5 mg of mifepristone daily for 6 months

Treatment:

Drug: Mifepristone

Group 2

Experimental group

Description:

Oral administration of 5 mg of mifepristone daily for 6 months

Treatment:

Drug: Mifepristone

Group 3

Experimental group

Description:

Oral administration of 10 mg of mifepristone daily for 6 months

Treatment:

Drug: Mifepristone

Group 4

Experimental group

Description:

Oral administration of mifepristone placebo daily for 3 months

Treatment:

Drug: PLACEBO