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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Poznan University of Medical Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of California, Davis
Biomet Polska Sp. z.o.o.
Information provided by:
Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00675779
First received: May 5, 2008
Last updated: May 9, 2008
Last verified: May 2008

May 5, 2008
May 9, 2008
April 2008
November 2010   (final data collection date for primary outcome measure)
pain relief [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00675779 on ClinicalTrials.gov Archive Site
inflammatory status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Active, not recruiting
44
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)
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00675779
204-08
No
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