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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mediterranea Medica S. L.
• Treatments: Mifepristone

Criteria

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.