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

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine if the addition of Low Dose Naltrexone to standard endometriosis treatments will improve patient reported endometriosis associated pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Naltrexone; Norethindrone; Norethindrone Acetate

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.

• Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis during the study period.

• Agrees to use contraception if not surgically sterile during the entire study.

• Patients using oral contraceptives, LARCs and/or GnRH agonists/antagonists for contraception and/or management of endometriosis, with a stable regimen, will be able to continue in the study, however, women using oral contraceptives and GnRH agonist/antagonists will be switched to Norethindrone acetate during the 1-2 week run-in period as prescribed by principle investigator.

Exclusion Criteria:

• Women that are pregnant, breastfeeding or trying to conceive.

• Patients with chronic daily narcotic use and any chronic pain or frequently reoccurring pain condition, other than endometriosis, that is treated with opioids or requires analgesics for more than 7 days per month.

• Patients with abnormal liver function tests (greater than 3x normal limit) in the past year or history of liver disease. Routine screening of liver function is not required.

• Non-English speaking or inability to read and understand English secondary, in part, to the need to read and report daily results in English.

• Undiagnosed vaginal bleeding

• Patients with history of opioid, illicit drug or alcohol abuse

• Patients currently taking thioridazine

• Patients with a history of suicidality

• Patients with current or history of unstable depression or other psychiatric disorder who, by PI judgement, are unstable or not well controlled

• Known, suspected or history of cancer of the breast

• Active deep vein thrombosis, pulmonary embolism or history of these conditions

• Active or recent arterial thromboembolic disease (e.g., stroke, myocardial infarction)