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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03970330
• Other study ID #: Study00011187
• Status: Terminated
• Phase: Phase 3
• Start date: January 16, 2020
• Est. completion date: June 21, 2021

Study information

• Verified date: October 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Naltrexone
4.5mg daily dose, taken orally
• Norethindrone Acetate
5 - 15mg daily dose, taken orally
• Placebo
daily placebo pill, taken orally

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	EHP-30 Score	Quality of life measured by the validated Endometriosis Health Profile (EHP-30) questionnaire. Scores range from 0 (best health status) to 100 (worst health status).	Baseline, 4, 8, 12, and 16 weeks
Secondary	PGIC Score (Painful Periods)	Patient's Global Impression of Change (PGIC) scale will be used to rate painful periods. This is a 7 point scale ranging from 1 (much worse) to 7 (much better).	4, 8, 12 and 16 weeks
Secondary	PGIC Score (Nonmenstrual Pelvic Pain)	Patient's Global Impression of Change (PGIC) scale will be used to rate nonmenstrual pelvic pain. This is a 7 point scale ranging from 1 (much worse) to 7 (much better).	4, 8, 12 and 16 weeks
Secondary	PGIC Score (Dyspareunia)	Patient's Global Impression of Change (PGIC) scale will be used to rate pelvic pain during sex. This is a 7 point scale ranging from 1 (much worse) to 7 (much better).	4, 8, 12 and 16 weeks
Secondary	Ibuprofen Use	Average # of ibuprofen 200 mg pills per week during the study treatment period	12 weeks
Secondary	Oxycodone Use	Number of subjects who used oxycodone at any time during the study	12 weeks