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

NCT03970330 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: Study00011187
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Keywords

endometriosis; pelvic pain; opioid; narcotic

Outcome Measures

Primary Outcomes (1)

• Pain Score Area Under the Curve (AUC)

  Pain is reported daily using the Visual Analog Scale, a 100mm horizontal line on which the patient's pain intensity is represented by a point between the extremities of 0 (no pain) and 100 (worst pain). The final outcome measure will be calculated as area under the curve from randomization through 12-weeks of intervention. AUC was calculated using the trapezoid rule. Calculated AUC per subject across this 12-week period can range from 0 - 8300.

  12 weeks

Secondary Outcomes (6)

• EHP-30 Score

  Baseline, 4, 8, 12, and 16 weeks

• PGIC Score (Painful Periods)

  4, 8, 12 and 16 weeks

• PGIC Score (Nonmenstrual Pelvic Pain)

  4, 8, 12 and 16 weeks

• PGIC Score (Dyspareunia)

  4, 8, 12 and 16 weeks

• Ibuprofen Use

  12 weeks

Study Arms (2)

Low-Dose Naltrexone

EXPERIMENTAL

12-week intervention period of 4.5 mg daily naltrexone in combination with standard treatment of 5-15 mg daily norethindrone acetate

Drug: Naltrexone; Drug: Norethindrone Acetate

Placebo

PLACEBO COMPARATOR

12-week intervention period of daily placebo in combination with standard treatment of 5-15 mg daily norethindrone acetate

Drug: Norethindrone Acetate; Drug: Placebo

Interventions

Naltrexone DRUG

4.5mg daily dose, taken orally

Also known as: REVIA

Low-Dose Naltrexone

Norethindrone Acetate DRUG

5 - 15mg daily dose, taken orally

Low-Dose Naltrexone; Placebo

Placebo DRUG

daily placebo pill, taken orally

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Endometriosis is specifically associated to females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Interventions

Naltrexone; Norethindrone Acetate

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Norethindrone; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Dr. Kristin Riley
• Organization: MSHersheyMC

kriley1@pennstatehealth.psu.edu

717-531-6447

Study Officials

• Kristin Riley, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor of Obstetrics and Gynecology

Model Details: Randomized, Double Blind, Placebo Controlled Trial

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 31, 2019
• Study Start: January 16, 2020
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: November 3, 2022
• Results First Posted: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available one year after publication according to PMCID journal guidelines.
• Access Criteria: Data will plan to be published in a peer-reviewed journal and /or posted at clinicaltrials.gov websites or other websites per request of the NIH. Materials will also be accessible through email contact of Primary Investigator.

Locations

US (1)