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

NCT03970330 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-11-03

Study results available
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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.

Conditions

  • Endometriosis

Interventions

DRUG

Naltrexone

4.5mg daily dose, taken orally

DRUG

Norethindrone Acetate

5 - 15mg daily dose, taken orally

DRUG

Placebo

daily placebo pill, taken orally

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Kristin Riley, MD · Milton S. Hershey Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2021-06-21
Completion
2021-06-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03970330 on ClinicalTrials.gov