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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-07-31

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.

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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

Conditions

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Endometriosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pravastatin

Pravastatin sodium 20mg PO daily

Group Type EXPERIMENTAL

Pravastatin

Intervention Type DRUG

20 mg pravastatin sodium daily for 3 months

Interventions

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Pravastatin

20 mg pravastatin sodium daily for 3 months

Intervention Type DRUG

Other Intervention Names

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pravastatin sodium

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No