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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Pravastatin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pravastatin<br>Pravastatin sodium 20mg PO daily | Drug: Pravastatin<br>* 20 mg pravastatin sodium daily for 3 months<br>* Other names: pravastatin sodium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective assessment of pain | Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, pain, fertility