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

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.

Timeline

Start

2020-01-16

Primary completion

2021-06-21

Completion

2021-06-21

Outcome

Missed primary endpoint

Stopped (Business): “Original PI left institution, lack of funding to continue”

registry analysis (superiority test); Low-Dose Naltrexone vs Placebo; p = 0.20; Mean Difference (Final Values) 1123 (95% CI -755 to 3000); t-test, 2 sided NCT03970330 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naltrexone	Small molecule	4.5 mg	Oral
Background	Norethindrone	Unknown	5 mg	Oral
Background	Norethindrone	Unknown	15 mg	Oral

Indications