Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis - Full Text View

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

First Received on May 5, 2008. Last Updated on May 9, 2008 History of Changes

Sponsor:	Poznan University of Medical Sciences
Collaborators:	University of California, Davis Biomet Polska Sp. z.o.o.
Information provided by:	Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00675779

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:

MedlinePlus related topics: Endometriosis Pelvic Pain

Drug Information available for: Dacuronium bromide Dacuronium Atorvastatin Atorvastatin calcium

U.S. FDA Resources

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

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
Pelvic Pain
Genital Diseases, Female
Pain
Signs and Symptoms
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Atorvastatin
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on February 09, 2012