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

Primary Purpose

Endometriosis, Pain

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
oral contraceptive (Mercilon)
atorvastatin + oral contraceptive
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring endometriosis, atorvastatin, oral, contraception, pain, relief, pelvic pain in women with endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Poznan University of Medical Sciences, Department of Gynecology and Obstetrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2

1

Arm Description

oral contraceptive + atorvastatin

oral contraceptive

Outcomes

Primary Outcome Measures

pain relief

Secondary Outcome Measures

inflammatory status

Full Information

First Posted
May 5, 2008
Last Updated
May 9, 2008
Sponsor
Poznan University of Medical Sciences
Collaborators
University of California, Davis, Biomet Polska Sp. z.o.o.
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1. Study Identification

Unique Protocol Identification Number
NCT00675779
Brief Title
Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis
Acronym
EndoStatin
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Poznan University of Medical Sciences
Collaborators
University of California, Davis, Biomet Polska Sp. z.o.o.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Pain
Keywords
endometriosis, atorvastatin, oral, contraception, pain, relief, pelvic pain in women with endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
oral contraceptive + atorvastatin
Arm Title
1
Arm Type
Active Comparator
Arm Description
oral contraceptive
Intervention Type
Drug
Intervention Name(s)
oral contraceptive (Mercilon)
Other Intervention Name(s)
Mercilon (Organon Schering-Plough, Poland)
Intervention Description
oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months
Intervention Type
Drug
Intervention Name(s)
atorvastatin + oral contraceptive
Other Intervention Name(s)
Atrox 20 (Biofarm sp. z o.o. , Poznan, Poland)
Intervention Description
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
Primary Outcome Measure Information:
Title
pain relief
Time Frame
3,6,12 months
Secondary Outcome Measure Information:
Title
inflammatory status
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni J Duleba, MD
Organizational Affiliation
University of California, Davies, USA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leszek Pawelczyk, MD PhD
Organizational Affiliation
Poznan University of Medical Sciences, Poland
Official's Role
Study Director
Facility Information:
Facility Name
Poznan University of Medical Sciences, Department of Gynecology and Obstetrics
City
Poznan
ZIP/Postal Code
60-535
Country
Poland

12. IPD Sharing Statement

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

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