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Trial record 1 of 1 for:    NCT03970330
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Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis

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ClinicalTrials.gov Identifier: NCT03970330
Recruitment Status : Not yet recruiting
First Posted : May 31, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Timothy A Deimling, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Naltrexone Drug: Norethindrone Acetate Drug: Placebo Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
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
Official Title: 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
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: Low-Dose Naltrexone
12-week intervention period of 4.5 mg daily naltrexone in combination with standard treatment of 5 mg daily norethindrone acetate
Drug: Naltrexone
4.5mg daily dose, taken orally
Other Name: REVIA

Drug: Norethindrone Acetate
5mg daily dose, taken orally

Placebo Comparator: Placebo
12-week intervention period of daily placebo in combination with standard treatment of 5 mg daily norethindrone acetate
Drug: Norethindrone Acetate
5mg daily dose, taken orally

Drug: Placebo
daily placebo pill, taken orally




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. Ibuprofen use [ Time Frame: 12 weeks ]
    Total # of ibuprofen 200mg pills taken during the course of the study

  6. Oxycodone use [ Time Frame: 12 weeks ]
    Total # of oxycodone 5mg pills taken during the course of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Endometriosis is specifically associated to females.
Accepts Healthy Volunteers:   No
Criteria

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 conformation 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970330


Contacts
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Contact: Heidi Watts, BSN 717-531-6272 hwatts@pennstatehealth.psu.edu
Contact: Sandra Eyer 717-531-6208 seyer@pennstatehealth.psu.edu

Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Timothy Deimling, MD Milton S. Hershey Medical Center

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Responsible Party: Timothy A Deimling, Vice Chair of Research, Asst. Director, Minimally Invasive GYN Surgery, Asst. Professor of Obstetrics and Gynecology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03970330     History of Changes
Other Study ID Numbers: Study00011187
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Timothy A Deimling, Milton S. Hershey Medical Center:
endometriosis
pelvic pain
opioid
narcotic

Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Naltrexone
Norethindrone
Norethindrone Acetate
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents