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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02079974
• Other study ID #: 4169720110
• Status: Withdrawn
• Phase: N/A
• Start date: July 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2020
• Source: Toronto Centre for Advanced Reproductive Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Other known NCT identifiers

• NCT02084667

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometriosis

Intervention

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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital, University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Robert F. Casper

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective assessment of pain	Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)	3 months