Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis
This trial is active, not recruiting.
|Treatments||oral contraceptive (mercilon), atorvastatin + oral contraceptive|
|Sponsor||Poznan University of Medical Sciences|
|Collaborator||University of California, Davis|
|Start date||April 2008|
|End date||November 2010|
|Trial size||44 participants|
|Trial identifier||NCT00675779, 204-08|
The purpose of this study is to determine whether atorvastatin (alone or in combination with oral contraceptive) is effective in treatment of pelvic pain and inflammatory response in women with endometriosis.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time frame: 3,6,12 months
time frame: 6 months
Female participants from 18 years up to 45 years old.
Inclusion Criteria: - informed written consent - premenopausal women aged 18-45 - clinical signs and symptoms of endometriosis for minimum 3 months with endometriosis confirmed at laparoscopy or laparotomy within last 4 months - 5 years (preferably with histological confirmation) - pain symptoms of moderate intensity (dysmenorrhoea + dyspareunia + nonmenstrual pelvic pain > 6 points on Biberoglu & Behrman scale ) - no clinical signs of sexually transmitted disease Exclusion Criteria: - cancer of the ovary, adrenals, endometrium, uterine cervix, breasts - pregnancy or lactation - unexplained uterine/cervical bleeding - hormonal therapy within last 3 months (for GnRH analogs 6 months) - irregular menses (> 35 days) or secondary amenorrhoea (>3 months) - other chronic disease affecting pelvic or abdominal cavity (including PID, ulcerating colitis , Crohn's disease, recurrent interstitial cystitis) - sexually transmitted disease (gonorrhoea, Chlamydia) - uncontrolled diabetes mellitus type I or II, VTE or other contraindications to medicine used in the study - chronic therapy with CYP3A4 inhibitors (including ketoconazole, erythromycin and others)
|Official title||Comparison of Pain Relief and Inflammatory Status in Women With Surgically Confirmed Endometriosis Treated With Atorvastatin, Oral Contraceptive or Combined Oral Contraceptives and Atorvastatin: Open Randomized Controlled Trial|
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