Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Naltrexone; Norethindrone Acetate; Placebo
Intervention description: 4.5mg daily dose, taken orally; 5 - 15mg daily dose, taken orally; daily placebo pill, taken orally
Intervention MeSH terms: Naltrexone; Norethindrone; Norethindrone Acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double Blind, Placebo Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: endometriosis; pelvic pain; opioid; narcotic

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.
    

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.

          -  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)