NCT03970330

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Naltrexone	4.5mg daily dose, taken orally
DRUG	Norethindrone Acetate	5 - 15mg daily dose, taken orally
DRUG	Placebo	daily placebo pill, taken orally

Timeline

• Start date: 2020-01-16
• Primary completion: 2021-06-21
• Completion: 2021-06-21
• First posted: 2019-05-31
• Last updated: 2022-11-03
• Results posted: 2022-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study