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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 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03970330
Study type Interventional
Source Milton S. Hershey Medical Center
Contact
Status Terminated
Phase Phase 3
Start date January 16, 2020
Completion date June 21, 2021
View Details
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