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

TerminatedPhase 3NCT03970330
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Randomized Double-Blind Placebo-Controlled Trial to Assess the Effectiveness of Low-Dose Naltrexone in Combination With Standard Treatment in Women With Chronic Pelvic Pain Secondary to Endometriosis
Conditions
Interventions
Sponsor
Milton S. Hershey Medical Center
Start date
2020-01-16
Primary completion
2021-06-21
Sex
Female
Age range
from 18 Years to 45 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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)

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03970330