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

Dr. Robert F. Casper

Status: Withdrawn

Conditions: Endometriosis

Treatments: Drug: Pravastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02079974

4169720110

Details and patient eligibility

About

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.

Full 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

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Pravastatin

Experimental group

Description:

Pravastatin sodium 20mg PO daily

Treatment:

Drug: Pravastatin