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

Not Applicable

• Conditions: Pain; Endometriosis
• Interventions: Drug: atorvastatin + oral contraceptive; Drug: oral contraceptive (Mercilon)

• Registration Number: NCT00675779
• Lead Sponsor: Poznan University of Medical Sciences

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 endometriosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Status Verified: 2008-05
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-09
• Last Update Submitted: 2008-05-09
• Study First Posted: 2008-05-12
• Last Update Posted: 2008-05-12
• Primary Completion: 2010-11
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 44

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	atorvastatin + oral contraceptive	oral contraceptive + atorvastatin
1	oral contraceptive (Mercilon)	oral contraceptive

Primary Outcome Measures

Name	Time	Method
pain relief	3,6,12 months

Secondary Outcome Measures

Name	Time	Method
inflammatory status	6 months

Trial Locations

Locations (1)

Poznan University of Medical Sciences, Department of Gynecology and Obstetrics; 🇵🇱 Poznan, Poland