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

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ClinicalTrials.gov Identifier: NCT00675779
Recruitment Status : Unknown
Verified May 2008 by Poznan University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : May 12, 2008
Last Update Posted : May 12, 2008
Information provided by:

May 5, 2008
May 12, 2008
May 12, 2008
April 2008
November 2010   (Final data collection date for primary outcome measure)
pain relief [ Time Frame: 3,6,12 months ]
Same as current
No Changes Posted
inflammatory status [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
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
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.
Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Endometriosis
  • Pain
  • 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 Name: 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 Name: Atrox 20 (Biofarm sp. z o.o. , Poznan, Poland)
  • Experimental: 2
    oral contraceptive + atorvastatin
    Intervention: Drug: atorvastatin + oral contraceptive
  • Active Comparator: 1
    oral contraceptive
    Intervention: Drug: oral contraceptive (Mercilon)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
March 2011
November 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Robert Z. Spaczynski, MD PhD, Poznan University of Medical Sciences
Poznan University of Medical Sciences
  • University of California, Davis
  • Biomet Polska Sp. z.o.o.
Study Chair: Antoni J Duleba, MD University of California, Davies, USA
Study Director: Leszek Pawelczyk, MD PhD Poznan University of Medical Sciences, Poland
Poznan University of Medical Sciences
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP