Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis

Recruiting in Palo Alto (17 mi)

Overseen byKristin Riley, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Milton S. Hershey Medical Center

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing whether adding a small dose of naltrexone to standard treatments can help reduce pain in patients with endometriosis. Endometriosis often causes significant pain, and current treatments may not be enough. Naltrexone, usually used for addiction, might help by reducing inflammation and calming pain signals. Low-dose naltrexone has been explored as a treatment for various chronic pain conditions, showing potential benefits in reducing pain and inflammation.

Eligibility Criteria

Inclusion Criteria

Premenopausal female ages 18 to 45 years old on the day of signing informed consent.

Must agree to use only study-specific analgesic medications during the study and is not known to be intolerant to them.

Diagnosed with endometriosis and has had, within the last 10 years prior to signing the informed consent, surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis.

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