EndometriosisNCT02079974
Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis
A study testing Pravastatin in people with Endometriosis, run by Dr. Robert F. Casper at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Pravastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female patients of reproductive age group (18-38 years) with a clinical or surgical diagnosis of endometriosis with pain symptoms
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Mount Sinai Hospital, University of Toronto
Toronto, Ontario, M5G 1X5
About this study
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
- Conditions
- Endometriosis
- Being tested
- Pravastatin
- Keywords
- endometriosis, pain, fertility
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PravastatinDrug
Also called pravastatin sodium
20 mg pravastatin sodium daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Pravastatin | Experimental | Pravastatin sodium 20mg PO daily Receives: Drug: Pravastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective assessment of pain
Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Robert F. Casper
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Robert F. Casper, Toronto Centre for Advanced Reproductive Technology
- Investigators
- Robert Casper, MD, Principal investigator, Dept of Obstetrics and Gynecology, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079974
- Sponsor's protocol ID
- 4169720110
- Status last verified
- Aug 2020
- First submitted
- 3 Mar 2014
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis
- ClinicalTrials.gov ID
- NCT02079974
- Acronym / sponsor ID
- 4169720110
- Conditions
- Endometriosis
- Keywords
- endometriosis, pain, fertility
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dr. Robert F. CasperUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pravastatin | Experimental | Drug: PravastatinPravastatin sodium 20mg PO daily |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female patients of reproductive age group (18-38 years) with a clinical or surgical diagnosis of endometriosis with pain symptoms
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PravastatinAlso: pravastatin sodium20 mg pravastatin sodium daily for 3 months | Drug | Pravastatin |
Primary outcome
subjective assessment of pain
Time frame: 3 months
Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Casper, MD principal investigator
Dept of Obstetrics and Gynecology, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pravastatin in people with Endometriosis, run by Dr. Robert F. Casper at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective assessment of pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.