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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02079974
Recruitment Status : Withdrawn
First Posted : March 6, 2014
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Robert F. Casper, Toronto Centre for Advanced Reproductive Technology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Pravastatin Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis
Study Start Date : July 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Pravastatin
Pravastatin sodium 20mg PO daily
 Drug: Pravastatin
20 mg pravastatin sodium daily for 3 months
Other Name: pravastatin sodium


Outcome Measures
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Primary Outcome Measures :
  1. subjective assessment of pain [ Time Frame: 3 months ]
    Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079974


Locations
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Canada, Ontario
Mount Sinai Hospital, University of Toronto
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Dr. Robert F. Casper
Investigators
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Principal Investigator: Robert Casper, MD Dept of Obstetrics and Gynecology, University of Toronto
More Information
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Responsible Party: Dr. Robert F. Casper, Professor, Dept of Obstetrics and Gynecology, Toronto Centre for Advanced Reproductive Technology
ClinicalTrials.gov Identifier: NCT02079974    
Obsolete Identifiers: NCT02084667
Other Study ID Numbers: 4169720110
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Keywords provided by Dr. Robert F. Casper, Toronto Centre for Advanced Reproductive Technology:
endometriosis
pain
fertility
Additional relevant MeSH terms:
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Endometriosis
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors