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

NCT02079974 — Not applicable, Withdrawn, Dr. Robert F. Casper

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Registry	NCT02079974
Status	Withdrawn
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Sponsor	Dr. Robert F. Casper (Other)
Conditions	Endometriosis
Interventions	Pravastatin (Drug)
Dates	start 2014-07-01, primary completion 2014-07-01, completion 2014-07-01, first posted 2014-03-06, last updated 2020-08-28
Locations	1 site in Canada

-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.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Pravastatin	Experimental	Drug: Pravastatin	Pravastatin sodium 20mg PO daily

Pravastatin (Drug), also known as pravastatin sodium: 20 mg pravastatin sodium daily for 3 months

+Outcome measures

Primary outcomes

subjective assessment of pain [3 months]: Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)

+Eligibility

Sex: Female, ages: 18 Years to 38 Years

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)

+Locations (1)

Facility	City	Country	Status
Mount Sinai Hospital, University of Toronto	Toronto, Ontario	Canada

+Investigators

Robert Casper, MD, Principal investigator, Dept of Obstetrics and Gynecology, University of Toronto