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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
497 Previous Clinical Trials
2,799,961 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
~2 spots leftby Jun 2025
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