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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02079974

Enrollment

Registered

2014-03-06

Start date

2014-07-31

Completion date

2014-07-31

Last updated

2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

endometriosis, pain, fertility

Brief 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.

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

Interventions

DRUGPravastatin

20 mg pravastatin sodium daily for 3 months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 38 Years

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)

Design outcomes

Primary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026