Status:
UNKNOWN
Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis
Lead Sponsor:
Poznan University of Medical Sciences
Collaborating Sponsors:
University of California, Davis
Biomet Polska Sp. z.o.o.
Conditions:
Endometriosis
Pain
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 endome...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00675779
Start Date
April 1 2008
End Date
March 1 2011
Last Update
May 12 2008
Active Locations (1)
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1
Poznan University of Medical Sciences, Department of Gynecology and Obstetrics
Poznan, Poland, 60-535