This trial is active, not recruiting.

Conditions endometriosis, pain
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
oral contraceptive + atorvastatin
atorvastatin + oral contraceptive Atrox 20 (Biofarm sp. z o.o. , Poznan, Poland)
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
(Active Comparator)
oral contraceptive
oral contraceptive (mercilon) Mercilon (Organon Schering-Plough, Poland)
oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months

Primary Outcomes

pain relief
time frame: 3,6,12 months

Secondary Outcomes

inflammatory status
time frame: 6 months

Eligibility Criteria

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 [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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Poznan University of Medical Sciences.