Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis

• Status: Unknown status
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poznan University of Medical Sciences
• Collaborators: Biomet Polska Sp. z.o.o.; University of California, Davis
• Treatments: Atorvastatin; Atorvastatin Calcium; Contraceptive Agents; Contraceptives, Oral; Dacuronium

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)