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
  Purpose

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
Endometriosis
Pain
Drug: oral contraceptive (Mercilon)
Drug: atorvastatin + oral contraceptive

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • inflammatory status [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675779

Locations
Poland
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
  More Information

No publications provided

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

Keywords provided by Poznan University of Medical Sciences:
endometriosis
atorvastatin
oral
contraception
pain
relief
pelvic pain in women with endometriosis

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Atorvastatin
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Anticholesteremic Agents
Antimetabolites
Contraceptive Agents, Female
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014