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

NCT02079974 | Withdrawn

• 1 other identifier: 4169720110
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

endometriosis; pain; fertility

Outcome Measures

Primary Outcomes (1)

• subjective assessment of pain

  Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)

  3 months

Study Arms (1)

Pravastatin

EXPERIMENTAL

Pravastatin sodium 20mg PO daily

Drug: Pravastatin

Interventions

Pravastatin DRUG

20 mg pravastatin sodium daily for 3 months

Also known as: pravastatin sodium

Pravastatin

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female patients of reproductive age group (18-38 years) with a clinical or surgical diagnosis of endometriosis with pain symptoms

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr. Robert F. Casper: lead

Study Sites (1)

Mount Sinai Hospital, University of Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Endometriosis; Pain

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Robert Casper, MD

  Dept of Obstetrics and Gynecology, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Dept of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 6, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

CA (1)