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

August 26, 2020 updated by: Dr. Robert F. Casper
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital, University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pravastatin
Pravastatin sodium 20mg PO daily
Drug: Pravastatin
20 mg pravastatin sodium daily for 3 months
Other Names:
  • pravastatin sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective assessment of pain
Time Frame: 3 months
Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Robert F. Casper

Investigators

  • Principal Investigator: Robert Casper, MD, Dept of Obstetrics and Gynecology, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (ESTIMATE)

March 6, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4169720110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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