Trial | NCT00675779  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    44
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.
Study Started
Apr 30
2008
Primary Completion
Nov 30
2010
Anticipated
Study Completion
Mar 31
2011
Anticipated
Last Update
May 12
2008
Estimate

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

  • Other names: Mercilon (Organon Schering-Plough, Poland)

Drug 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

  • Other names: Atrox 20 (Biofarm sp. z o.o. , Poznan, Poland)

2 Experimental

oral contraceptive + atorvastatin

1 Active Comparator

oral contraceptive

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)
No Results Posted