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Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis

Primary Purpose

Endometriosis

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pravastatin
Sponsored by
Dr. Robert F. Casper
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring endometriosis, pain, fertility

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female patients of reproductive age group (18-38 years) with a clinical or surgical diagnosis of endometriosis with pain symptoms

Exclusion Criteria:

  • use of hormonal suppression for pain control (OCP, GnRHa) within 6-months
  • history of surgery for endometriosis within 6- months
  • current renal or hepatic active disease
  • current or history of myopathic disease
  • medication that may interact with statins (erythromycin, gemfibrosil, antifungals, antiretrovirals, other cholesterol lowering drugs)

Sites / Locations

  • Mount Sinai Hospital, University of Toronto

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pravastatin

Arm Description

Pravastatin sodium 20mg PO daily

Outcomes

Primary Outcome Measures

subjective assessment of pain
Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)

Secondary Outcome Measures

Full Information

First Posted
March 3, 2014
Last Updated
August 26, 2020
Sponsor
Dr. Robert F. Casper
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1. Study Identification

Unique Protocol Identification Number
NCT02079974
Brief Title
Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis
Official Title
Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Robert F. Casper

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Endometriosis is a chronic inflammatory disorder leading to painful periods, pain with intercourse and infertility. The available treatment options to alleviate pain involve mainly hormonal treatments and surgery. All current hormonal treatments are effective but disrupt the normal variations in reproductive hormones which prevent ovulation, and thus pregnancy. Statins, a group of cholesterol lowering drugs, have anti-inflammatory properties which may be helpful also for the pain related to endometriosis. The investigators plan to undertake a pilot study of 10 patients with endometriosis who will take pravastatin sodium together with coQ10, which is inhibited by statins, for a period of 3 months. If this pilot study shows that the statin treatment may decrease pain symptoms in endometriosis, then the investigators plan to undertake a larger study to further investigate this matter.
Detailed Description
Initial grading of pain by a Linear Analogue Scale (LAS) from 1-10 Initial blood biochemistry including liver function test, lipid profile, creatine/BUN, creatine kinase 3 months of treatment with statins (Pravastatin) in a dose of 40mg daily Supplementation with CoQ10 (200mg) daily for 3 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
endometriosis, pain, fertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pravastatin
Arm Type
Experimental
Arm Description
Pravastatin sodium 20mg PO daily
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Other Intervention Name(s)
pravastatin sodium
Intervention Description
20 mg pravastatin sodium daily for 3 months
Primary Outcome Measure Information:
Title
subjective assessment of pain
Description
Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female patients of reproductive age group (18-38 years) with a clinical or surgical diagnosis of endometriosis with pain symptoms Exclusion Criteria: use of hormonal suppression for pain control (OCP, GnRHa) within 6-months history of surgery for endometriosis within 6- months current renal or hepatic active disease current or history of myopathic disease medication that may interact with statins (erythromycin, gemfibrosil, antifungals, antiretrovirals, other cholesterol lowering drugs)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Casper, MD
Organizational Affiliation
Dept of Obstetrics and Gynecology, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital, University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada

12. IPD Sharing Statement

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Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis

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