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

Pain Clinical Trial

— EndoStatin  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00675779
• Other study ID #: 204-08
• Status: Active, not recruiting
• Phase: N/A
• First received: May 5, 2008
• Last updated: May 9, 2008
• Start date: April 2008
• Est. completion date: March 2011

Study information

• Verified date: May 2008
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: March 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• Pain

Intervention

Drug:
• oral contraceptive (Mercilon)
oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months
• atorvastatin + oral contraceptive
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

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences, Department of Gynecology and Obstetrics	Poznan

Sponsors (3)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences	Biomet Polska Sp. z.o.o., University of California, Davis

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain relief		3,6,12 months	No
Secondary	inflammatory status		6 months	No