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Sponsors and Collaborators: |
Poznan University of Medical Sciences University of California, Davis Biomet Polska Sp. z.o.o. |
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Information provided by: | Poznan University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00675779 |
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 | Intervention |
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Endometriosis Pain |
Drug: oral contraceptive (Mercilon) Drug: atorvastatin + oral contraceptive |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 44 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Experimental
oral contraceptive + atorvastatin
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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
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1: Active Comparator
oral contraceptive
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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
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Poland | |
Poznan University of Medical Sciences, Department of Gynecology and Obstetrics | |
Poznan, Poland, 60-535 |
Study Chair: | Antoni J Duleba, MD | University of California, Davies, USA |
Study Director: | Leszek Pawelczyk, MD PhD | Poznan University of Medical Sciences, Poland |
Responsible Party: | Poznan University of Medical Sciences ( Robert Z. Spaczynski, MD PhD ) |
Study ID Numbers: | 204-08 |
Study First Received: | May 5, 2008 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00675779 History of Changes |
Health Authority: | Poland: Ministry of Health |
endometriosis atorvastatin oral contraception |
pain relief pelvic pain in women with endometriosis |
Antimetabolites Contraceptive Agents Antilipemic Agents Contraceptives, Oral Contraceptive Agents, Female Pain Endometriosis |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Genital Diseases, Female Contraceptives, Oral, Combined Pelvic Pain Atorvastatin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Contraceptive Agents Antilipemic Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Enzyme Inhibitors Endometriosis |
Reproductive Control Agents Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Genital Diseases, Female Contraceptives, Oral, Combined Therapeutic Uses Atorvastatin |