Status:
COMPLETED
Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis
Lead Sponsor:
Mediterranea Medica S. L.
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
PHASE3
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 hypothesi...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT02271958
Start Date
November 1 2010
End Date
December 1 2013
Last Update
October 22 2014
Active Locations (1)
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1
Hospital Eusebio Hernández, "Maternidad Obrera"
Havana, La Habana, Cuba