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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 5, 2008

Last Updated Date

May 9, 2008

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

pain relief [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00675779 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

inflammatory status [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Endometriosis
Pain

Intervention ^ICMJE

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)

Study Arm (s)

Experimental: 2
oral contraceptive + atorvastatin

Intervention: Drug: atorvastatin + oral contraceptive
Active Comparator: 1
oral contraceptive

Intervention: Drug: oral contraceptive (Mercilon)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2011

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT00675779

Other Study ID Numbers ^ICMJE

204-08

Has Data Monitoring Committee

Responsible Party

Robert Z. Spaczynski, MD PhD, Poznan University of Medical Sciences

Study Sponsor ^ICMJE

Poznan University of Medical Sciences

Collaborators ^ICMJE

University of California, Davis
Biomet Polska Sp. z.o.o.

Investigators ^ICMJE

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

Information Provided By

Poznan University of Medical Sciences

Verification Date

May 2008

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

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