Clincosm LogoSign in Get a demo

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

Sponsor
Dr. Robert F. Casper (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02079974
Collaborator
(none)
0
Enrollment
1
Location
1
Arm

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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

Study Type:
Interventional
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 :
Jul 1, 2014
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pravastatin

Pravastatin sodium 20mg PO daily

Drug: Pravastatin
20 mg pravastatin sodium daily for 3 months
Other Names:
  • pravastatin sodium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. subjective assessment of pain [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Mount Sinai Hospital, University of Toronto Toronto Ontario Canada M5G 1X5

    Sponsors and Collaborators

    • Dr. Robert F. Casper

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Robert F. Casper, Professor, Dept of Obstetrics and Gynecology, Toronto Centre for Advanced Reproductive Technology
    ClinicalTrials.gov Identifier:
    NCT02079974
    Other Study ID Numbers:
    • 4169720110
    • NCT02084667
    First Posted:
    Mar 6, 2014
    Last Update Posted:
    Aug 28, 2020
    Last Verified:
    Aug 1, 2020
    Keywords provided by Dr. Robert F. Casper, Professor, Dept of Obstetrics and Gynecology, Toronto Centre for Advanced Reproductive Technology
    endometriosis
    pain
    fertility
    Additional relevant MeSH terms:
    Endometriosis
    Pravastatin

    Study Results

    No Results Posted as of Aug 28, 2020