Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis (EndoStatin)

Poznan University of Medical Sciences (PUMS)

Status

Unknown

Conditions

Endometriosis

Pain

Treatments

Drug: atorvastatin + oral contraceptive

Drug: oral contraceptive (Mercilon)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00675779

204-08

Details and patient eligibility

About

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.

Enrollment

44 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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)