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

NCT ID: NCT03970330

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-16
• Study Completion Date: 2021-06-21

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.

Detailed Description

The central hypothesis of the research study is that low dose naltrexone (LDN), in combination with hormonal suppression of endometriosis (standard of care), will lead to significant improvement of endometriosis-related pain.

The proposal seeks to:

1. determine if the addition of LDN to standard endometriosis treatments will improve patient- reported endometriosis associated pain using daily Visual Analogue Scale (VAS) scores and

2. measure the impact of treatment on quality of life as measured by validated questionnaires including the Endometriosis Health Profile-30 (EHP30) and the Patient's Global Impression of Change (PGIC).

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low-Dose Naltrexone

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

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

4.5mg daily dose, taken orally

Norethindrone Acetate

Intervention Type: DRUG

5 - 15mg daily dose, taken orally

Placebo

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

Group Type: PLACEBO_COMPARATOR

Norethindrone Acetate

Intervention Type: DRUG

5 - 15mg daily dose, taken orally

Placebo

Intervention Type: DRUG

daily placebo pill, taken orally

Interventions

Naltrexone

4.5mg daily dose, taken orally

Intervention Type: DRUG

Norethindrone Acetate

5 - 15mg daily dose, taken orally

Intervention Type: DRUG

Placebo

daily placebo pill, taken orally

Intervention Type: DRUG

Other Intervention Names

REVIA

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kristin Riley, MD

Asst. Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Riley, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Study00011187

Identifier Type: -

Identifier Source: org_study_id