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Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03970330
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Timothy A Deimling, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date June 22, 2020
Actual Study Start Date  ICMJE January 16, 2020
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
Pain Score [ Time Frame: 12 weeks ]
Pain will be 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 and normalized per participant to an average AUC score per week.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • EHP-30 Score [ Time Frame: Baseline, 4, 8, 12, and 16 weeks ]
    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).
  • PGIC Score (painful periods) [ Time Frame: 4, 8, 12 and 16 weeks ]
    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).
  • PGIC Score (nonmenstrual pelvic pain) [ Time Frame: 4, 8, 12 and 16 weeks ]
    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).
  • PGIC Score (dyspareunia) [ Time Frame: 4, 8, 12 and 16 weeks ]
    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).
  • Ibuprofen use [ Time Frame: 12 weeks ]
    Total # of ibuprofen 200mg pills taken during the course of the study
  • Oxycodone use [ Time Frame: 12 weeks ]
    Total # of oxycodone 5mg pills taken during the course of the study
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • EHP-30 Score [ Time Frame: Baseline, 4, 8, 12, and 16 weeks ]
    Quality of Life among women with endometriosis measured by the validated Endometriosis Health Profile (EHP30) questionnaire
  • PGIC Score [ Time Frame: Baseline, 4, 8, 12 and 16 weeks ]
    Quality of Life among women with endometriosis measured by the validated Patient's Global Impression of Change (PGIC) questionnaire
  • Ibuprofen use [ Time Frame: 12 weeks ]
    Total # of ibuprofen 200mg pills taken during the course of the study
  • Oxycodone use [ Time Frame: 12 weeks ]
    Total # of oxycodone 5mg pills taken during the course of the study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, Double Blind, Placebo Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: Naltrexone
    4.5mg daily dose, taken orally
    Other Name: REVIA
  • Drug: Norethindrone Acetate
    5 - 15mg daily dose, taken orally
  • Drug: Placebo
    daily placebo pill, taken orally
Study Arms  ICMJE
  • Experimental: Low-Dose Naltrexone
    12-week intervention period of 4.5 mg daily naltrexone in combination with standard treatment of 5-15 mg daily norethindrone acetate
    Interventions:
    • Drug: Naltrexone
    • Drug: Norethindrone Acetate
  • Placebo Comparator: Placebo
    12-week intervention period of daily placebo in combination with standard treatment of 5-15 mg daily norethindrone acetate
    Interventions:
    • Drug: Norethindrone Acetate
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2023
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Premenopausal female ages 18 to 45 years old on the day of signing informed consent.
  • Must agree to use only study-specific analgesic medications during the study and is not known to be intolerant to them.
  • Diagnosed with endometriosis and has had, within the last 10 years prior to signing the informed consent, surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis.
  • Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis during the study period.
  • Agrees to use contraception if not surgically sterile during the entire study.
  • Patients using oral contraceptives, LARCs and/or GnRH agonists/antagonists for contraception and/or management of endometriosis, with a stable regimen, will be able to continue in the study, however, women using oral contraceptives and GnRH agonist/antagonists will be switched to Norethindrone acetate during the 1-2 week run-in period as prescribed by principle investigator.

Exclusion Criteria:

  • Women that are pregnant, breastfeeding or trying to conceive.
  • Patients with chronic daily narcotic use and any chronic pain or frequently reoccurring pain condition, other than endometriosis, that is treated with opioids or requires analgesics for more than 7 days per month.
  • Patients with abnormal liver function tests (greater than 3x normal limit) in the past year or history of liver disease. Routine screening of liver function is not required.
  • Non-English speaking or inability to read and understand English secondary, in part, to the need to read and report daily results in English.
  • Undiagnosed vaginal bleeding
  • Patients with history of opioid, illicit drug or alcohol abuse
  • Patients currently taking thioridazine
  • Patients with a history of suicidality
  • Patients with current or history of unstable depression or other psychiatric disorder who, by PI judgement, are unstable or not well controlled
  • Known, suspected or history of cancer of the breast
  • Active deep vein thrombosis, pulmonary embolism or history of these conditions
  • Active or recent arterial thromboembolic disease (e.g., stroke, myocardial infarction)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Endometriosis is specifically associated to females.
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heidi Watts, BSN 717-531-6272 hwatts@pennstatehealth.psu.edu
Contact: Sandra Eyer 717-531-6208 seyer@pennstatehealth.psu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03970330
Other Study ID Numbers  ICMJE Study00011187
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Participant data will be shared that underlie the results reported in this article, after deidentification. Documents that will be available are the study protocol, statistical analysis plan, informed consent. Analyses is to achieve the study aims in the approved proposal.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data will be available one year after publication according to PMCID journal guidelines.
Access Criteria: Data will plan to be published in a peer-reviewed journal and /or posted at clinicaltrials.gov websites or other websites per request of the NIH. Materials will also be accessible through email contact of Primary Investigator.
Responsible Party Timothy A Deimling, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy Deimling, MD Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP