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1 Study Matches

A randomized double-blind placebo controlled trial to assess the effectiveness of low-dose naltrexone in combination with standard treatment in women with chronic pelvic pain secondary to endometriosis.

Pelvic pain associated with endometriosis is in part due to inflammation of a layer of tissue in the abdomen (stomach area). This leads to the great potential of relieving endometriosis related pelvic pain in a non-narcotic medication by decreasing the inflammation. The purpose of this study is to evaluate how a low dose of naltrexone compared to placebo (inactive substance) impacts your daily pain and the quality of your life with endometriosis. Naltrexone is approved by the U.S. Food and Drug Adminstration (FDA) for the treatment of opioid overdose and addiction. At much lower doses, naltrexone has been shown to be beneficial in pain relief of inflammatory disorders with promising results, but the use of the low dose in this study to treat endometriosis pain is investigational and has not been approved by the FDA.
Heidi Watts at hwatts@pennstatehealth.psu.edu or 717-531-6272
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03970330
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Inclusion Criteria:
Surgical diagnosis of endometriosis within last 10 years
Pelvic Pain associated with endometriosis
age 18-45
Exclusion Criteria:
Daily opioid use
Pregnant
Breast Feeding
Allergy to oxycodone, motrin, naltrexone
Pain Management, Women's Health
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Location
Hershey, PA