Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis
Information source: Poznan University of Medical Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometriosis; Pain
Intervention: oral contraceptive (Mercilon) (Drug); atorvastatin + oral contraceptive (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Poznan University of Medical Sciences Official(s) and/or principal investigator(s):
Antoni J Duleba, MD, Study Chair, Affiliation: University of California, Davies, USA
Leszek Pawelczyk, MD PhD, Study Director, Affiliation: Poznan University of Medical Sciences, Poland
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: pain relief
Secondary outcome: inflammatory status
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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)
Locations and Contacts
Poznan University of Medical Sciences, Department of Gynecology and Obstetrics, Poznan 60-535, Poland
Additional Information
Starting date: April 2008
Ending date: March 2011
Last updated: May 9, 2008
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