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.
The central hypothesis of the research study is that low dose naltrexone (LDN), in combination with hormonal suppression of endometriosis (standard of care), will lead to significant improvement of endometriosis-related pain. The proposal seeks to: 1. determine if the addition of LDN to standard endometriosis treatments will improve patient- reported endometriosis associated pain using daily Visual Analogue Scale (VAS) scores and 2. measure the impact of treatment on quality of life as measured by validated questionnaires including the Endometriosis Health Profile-30 (EHP30) and the Patient's Global Impression of Change (PGIC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9
4.5mg daily dose, taken orally
5 - 15mg daily dose, taken orally
daily placebo pill, taken orally
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Pain Score Area Under the Curve (AUC)
Pain is reported daily using the Visual Analog Scale, a 100mm horizontal line on which the patient's pain intensity is represented by a point between the extremities of 0 (no pain) and 100 (worst pain). The final outcome measure will be calculated as area under the curve from randomization through 12-weeks of intervention. AUC was calculated using the trapezoid rule. Calculated AUC per subject across this 12-week period can range from 0 - 8300.
Time frame: 12 weeks
EHP-30 Score
Quality of life measured by the validated Endometriosis Health Profile (EHP-30) questionnaire. Scores range from 0 (best health status) to 100 (worst health status).
Time frame: Baseline, 4, 8, 12, and 16 weeks
PGIC Score (Painful Periods)
Patient's Global Impression of Change (PGIC) scale will be used to rate painful periods. This is a 7 point scale ranging from 1 (much worse) to 7 (much better).
Time frame: 4, 8, 12 and 16 weeks
PGIC Score (Nonmenstrual Pelvic Pain)
Patient's Global Impression of Change (PGIC) scale will be used to rate nonmenstrual pelvic pain. This is a 7 point scale ranging from 1 (much worse) to 7 (much better).
Time frame: 4, 8, 12 and 16 weeks
PGIC Score (Dyspareunia)
Patient's Global Impression of Change (PGIC) scale will be used to rate pelvic pain during sex. This is a 7 point scale ranging from 1 (much worse) to 7 (much better).
Time frame: 4, 8, 12 and 16 weeks
Ibuprofen Use
Average # of ibuprofen 200 mg pills per week during the study treatment period
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Time frame: 12 weeks
Oxycodone Use
Number of subjects who used oxycodone at any time during the study
Time frame: 12 weeks