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WithdrawnNCT02079974Updated Aug 28, 2020

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

An interventional study of Pravastatin in Endometriosis, sponsored by Dr. Robert F. Casper. Withdrawn at 1 site in Canada. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2020-08-28.

Sponsored by Dr. Robert F. Casper · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 38 Years
Sex
Female
01

Study 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.

Read the 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
02

Conditions studied

  • Endometriosis

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Keywords

  • endometriosis
  • pain
  • fertility
03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

Browse Endometriosis studies →

Lead sponsor

This is the only study on the registry with Dr. Robert F. Casper as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Pravastatin

    Pravastatin sodium 20mg PO daily

    Drug: Pravastatin

Interventions

  • DrugPravastatin

    20 mg pravastatin sodium daily for 3 months

    Also known as: pravastatin sodium

06

What researchers measure

Primary outcomes

  1. subjective assessment of pain

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

    Time frame: 3 months

07

Study locations

1 site
  • Mount Sinai Hospital, University of Toronto
    Toronto, Ontario M5G 1X5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02079974
Lead sponsor
Dr. Robert F. Casper
Responsible party
Dr. Robert F. Casper (Professor, Dept of Obstetrics and Gynecology, Toronto Centre for Advanced Reproductive Technology) — Sponsor-investigator
First posted
Mar 6, 2014
Start date
Jul 2014
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Aug 28, 2020

Study contacts

Robert Casper, MD
principal investigator · Dept of Obstetrics and Gynecology, University of Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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