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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02271958 |
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Date of registration:
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04/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis
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Scientific title:
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Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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360 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02271958 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Cuba
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Contacts
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Name:
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Josep Ll Carbonell, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Clinic Mediterranea |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Endometriosis
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Intervention(s)
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Drug: Mifepristone
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Drug: PLACEBO
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Primary Outcome(s)
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Changes in prevalence of dysmenorrhea and the average reduction in its intensity.
[Time Frame: 6 months]
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Changes in scores according to American Fertility Society (AFS)
[Time Frame: 6 months]
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Incidence of hot flushes, nausea, dizzy spells, vomiting, fatigue/tiredness, raised hepatic transaminases, histological alterations of the endometrium.
[Time Frame: 6 months]
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Secondary ID(s)
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Endomife 2,5/5/10/placebo
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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