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

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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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date  ICMJE March 3, 2014
First Posted Date  ICMJE March 6, 2014
Last Update Posted Date August 28, 2020
Study Start Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
subjective assessment of pain [ Time Frame: 3 months ]
Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2014)
pain [ Time Frame: 3 months ]
Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis
Official Title  ICMJE Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE Drug: Pravastatin
20 mg pravastatin sodium daily for 3 months
Other Name: pravastatin sodium
Study Arms  ICMJE Experimental: Pravastatin
Pravastatin sodium 20mg PO daily
Intervention: Drug: Pravastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 5, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2014)
20
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02079974
Other Study ID Numbers  ICMJE 4169720110
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Robert F. Casper, Toronto Centre for Advanced Reproductive Technology
Study Sponsor  ICMJE Dr. Robert F. Casper
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Casper, MD Dept of Obstetrics and Gynecology, University of Toronto
PRS Account Toronto Centre for Advanced Reproductive Technology
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP