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Clinical Trial Name - Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis
| Original Study ID : 204-08 |
| NCT ID : NCT00675779 |
| Brief Title : Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis |
| 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 |
| Brief Summary : 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. |
| Source : Poznan University of Medical Sciences |
| Overall Status : Active, not recruiting |
| Start Date : April 2008 |
| End Date : March 2011 |
| Completion Date : March 2011 |
| Official Title : N/A |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Enrollment : 44 |
| Verification Date : May 2008 |
| First Received Date : May 5, 2008 |
| Trial Eligibility |
| Criteria : 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 [1981]) - 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) |
| Gender : Female |
| Minimum Age : 18 Years |
| Maximum Age : 45 Years |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Poznan University of Medical Sciences, Department of Gynecology and Obstetrics |
| City : Poznan |
| Zip Code : 60-535 |
| Country : Poland |
| OutComes |
| Primary OutComes |
| Measure : pain relief |
| Time Frame : 3,6,12 months |
| Safety issue : No |
| Secondary OutComes |
| Measure : inflammatory status |
| Time Frame : 6 months |
| Safety issue : No |
| Interventions |
| Type : Drug |
| Name : oral contraceptive (Mercilon) |
| Description : oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months |
| Type : Drug |
| Name : atorvastatin + oral contraceptive |
| Description : atorvastatin 20mg po a day for 6 months + oral contraceptive (20ug EE, 150ug DSG) 1 tablet po a day for 21 days with 7 day break for 6 months |
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