EndoStatin: Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 2 oral contraceptive + atorvastatin |
Drug: atorvastatin + oral contraceptive
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
Other Names:
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Active Comparator: 1 oral contraceptive |
Drug: oral contraceptive (Mercilon)
oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months
Other Names:
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Outcome Measures
Primary Outcome Measures
- pain relief [3,6,12 months]
Secondary Outcome Measures
- inflammatory status [6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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informed written consent
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premenopausal women aged 18-45
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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)
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pain symptoms of moderate intensity (dysmenorrhoea + dyspareunia + nonmenstrual pelvic pain > 6 points on Biberoglu & Behrman scale [1981])
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no clinical signs of sexually transmitted disease
Exclusion Criteria:
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cancer of the ovary, adrenals, endometrium, uterine cervix, breasts
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pregnancy or lactation
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unexplained uterine/cervical bleeding
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hormonal therapy within last 3 months (for GnRH analogs 6 months)
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irregular menses (> 35 days) or secondary amenorrhoea (>3 months)
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other chronic disease affecting pelvic or abdominal cavity (including PID, ulcerating colitis , Crohn's disease, recurrent interstitial cystitis)
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sexually transmitted disease (gonorrhoea, Chlamydia)
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uncontrolled diabetes mellitus type I or II, VTE or other contraindications to medicine used in the study
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chronic therapy with CYP3A4 inhibitors (including ketoconazole, erythromycin and others)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Poznan University of Medical Sciences, Department of Gynecology and Obstetrics | Poznan | Poland | 60-535 |
Sponsors and Collaborators
- Poznan University of Medical Sciences
- University of California, Davis
- Biomet Polska Sp. z.o.o.
Investigators
- Study Chair: Antoni J Duleba, MD, University of California, Davies, USA
- Study Director: Leszek Pawelczyk, MD PhD, Poznan University of Medical Sciences, Poland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 204-08