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

Sponsor
Poznan University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT00675779
Collaborator
University of California, Davis (Other), Biomet Polska Sp. z.o.o. (Industry)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: oral contraceptive (Mercilon)
  • Drug: atorvastatin + oral contraceptive
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Apr 1, 2008
Anticipated Primary Completion Date :
Nov 1, 2010
Anticipated Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 2

oral contraceptive + atorvastatin

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)
  • Active Comparator: 1

    oral contraceptive

    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)
  • Outcome Measures

    Primary Outcome Measures

    1. pain relief [3,6,12 months]

    Secondary Outcome Measures

    1. inflammatory status [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Poznan University of Medical Sciences, Department of Gynecology and Obstetrics Poznan Poland 60-535

    Sponsors and Collaborators

    • Poznan University of Medical Sciences
    • University of California, Davis
    • Biomet Polska Sp. z.o.o.

    Investigators

    • Study Chair: Antoni J Duleba, MD, University of California, Davies, USA
    • Study Director: Leszek Pawelczyk, MD PhD, Poznan University of Medical Sciences, Poland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00675779
    Other Study ID Numbers:
    • 204-08
    First Posted:
    May 12, 2008
    Last Update Posted:
    May 12, 2008
    Last Verified:
    May 1, 2008

    Study Results

    No Results Posted as of May 12, 2008