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

Not Applicable

Withdrawn

• Conditions: Endometriosis
• Interventions: Drug: Pravastatin

• Registration Number: NCT02079974
• Lead Sponsor: Dr. Robert F. Casper

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 Timeline

• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-06
• Study Start: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pravastatin	Pravastatin	Pravastatin sodium 20mg PO daily

Primary Outcome Measures

Name	Time	Method
subjective assessment of pain	3 months	Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)

Trial Locations

Locations (1)

Mount Sinai Hospital, University of Toronto; 🇨🇦 Toronto, Ontario, Canada