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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Poznan University of Medical Sciences.
Recruitment status was:  Active, not recruiting
University of California, Davis
Biomet Polska Sp. z.o.o.
Information provided by:
Poznan University of Medical Sciences Identifier:
First received: May 5, 2008
Last updated: May 9, 2008
Last verified: May 2008
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 Intervention
Drug: oral contraceptive (Mercilon)
Drug: atorvastatin + oral contraceptive

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Poznan University of Medical Sciences:

Primary Outcome Measures:
  • pain relief [ Time Frame: 3,6,12 months ]

Secondary Outcome Measures:
  • inflammatory status [ Time Frame: 6 months ]

Estimated Enrollment: 44
Study Start Date: April 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Mercilon (Organon Schering-Plough, Poland)


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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)
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Please refer to this study by its identifier: NCT00675779

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

Responsible Party: Robert Z. Spaczynski, MD PhD, Poznan University of Medical Sciences Identifier: NCT00675779     History of Changes
Other Study ID Numbers: 204-08
Study First Received: May 5, 2008
Last Updated: May 9, 2008

Keywords provided by Poznan University of Medical Sciences:
pelvic pain in women with endometriosis

Additional relevant MeSH terms:
Pelvic Pain
Genital Diseases, Female
Neurologic Manifestations
Signs and Symptoms
Atorvastatin Calcium
Contraceptive Agents
Contraceptives, Oral
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents processed this record on May 25, 2017