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Naltrexone for Endometriosis

Phase 3
Waitlist Available
Led By Kristin Riley, 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
Pivotal Trial

Summary

This trial is testing whether adding a small dose of naltrexone to standard treatments can help reduce pain in patients with endometriosis. Endometriosis often causes significant pain, and current treatments may not be enough. Naltrexone, usually used for addiction, might help by reducing inflammation and calming pain signals. Low-dose naltrexone has been explored as a treatment for various chronic pain conditions, showing potential benefits in reducing pain and inflammation.

Eligible Conditions
  • Endometriosis

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain Score Area Under the Curve (AUC)
Secondary study objectives
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
508 Previous Clinical Trials
2,796,355 Total Patients Enrolled
7 Trials studying Endometriosis
597 Patients Enrolled for Endometriosis
Kristin Riley, MDPrincipal InvestigatorMilton S. Hershey Medical Center
Timothy Deimling, MDPrincipal InvestigatorMilton S. Hershey Medical Center
~2 spots leftby Nov 2025
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