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Naltrexone for Endometriosis

Phase 3
Waitlist Available
Led By Timothy Deimling, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4, 8, 12 and 16 weeks
Awards & highlights

Study Summary

This trial is testing whether adding Low Dose Naltrexone to standard endometriosis treatments can help reduce endometriosis-related pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 8, 12 and 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 8, 12 and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain Score Area Under the Curve (AUC)
Secondary outcome measures
EHP-30 Score
Ibuprofen Use
Oxycodone Use
+3 more

Side effects data

From 2011 Phase 4 trial • 165 Patients • NCT00006489
24%
Nausea
12%
Headache
12%
Cold
10%
Dry Mouth
10%
Fatigue
7%
Gastrointestinal Issues
7%
Muscle Aches
7%
Vomiting
7%
Serious Suicidal Ideation
5%
Constipation
5%
Diarrhea
5%
Stomach Virus
5%
Changes to Vision
5%
Loose Stool
5%
Increased Irritability
5%
Sedation
5%
Stomach Pain
5%
Increased Bowel Movements
2%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naltrexone + Supportive Counseling
Naltrexone + CBT (Prolonged Exposure Therapy)
Placebo + CBT (Prolonged Exposure Therapy)
Placebo + Supportive Counseling

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Low-Dose NaltrexoneExperimental Treatment2 Interventions
12-week intervention period of 4.5 mg daily naltrexone in combination with standard treatment of 5-15 mg daily norethindrone acetate
Group II: PlaceboPlacebo Group2 Interventions
12-week intervention period of daily placebo in combination with standard treatment of 5-15 mg daily norethindrone acetate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
2005
Completed Phase 4
~2420
Norethindrone Acetate
2010
Completed Phase 3
~1730

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
494 Previous Clinical Trials
2,798,833 Total Patients Enrolled
6 Trials studying Endometriosis
567 Patients Enrolled for Endometriosis
Timothy Deimling, MDPrincipal InvestigatorMilton S. Hershey Medical Center
Kristin Riley, MDPrincipal InvestigatorMilton S. Hershey Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis
Kristin Riley, MD 2020. "Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03970330.
~2 spots leftby Apr 2025
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