Study of Electro-kinetically Modified Water for the Treatment of Pain Associated With Endometriosis

A Double Blind, Placebo-controlled Study Evaluating an Electro-kinetically Modified Water for the Treatment of Pain Associated With Endometriosis

The purpose of this study is to evaluate the efficacy of electro-kinetically modified water (EMW) beverage, consumed twice daily (BID) for 3 months in the management of endometriosis associated pain, and to evaluate the effect of EMW consumption on analgesic use for endometriosis associated pain.

Study Overview

• Status: Terminated
• Conditions: Pelvic Pain
• Intervention / Treatment: Other: Electro-kinetically Modified Water; Other: Placebo

Detailed Description

This is a single center, double-blind, placebo controlled, randomized study to assess the efficacy of EMW versus placebo in the treatment of premenopausal women (16-49 years of age) with endometriosis associated pain. Approximately 40 subjects with endometriosis will be enrolled at Madigan Army Medical Center (MAMC). Subjects will be asked to consume EMW (or placebo) for three months. Subjects will record daily pain levels and other symptoms associated with endometriosis in an electronic diary. In addition to standard of care for this condition, the investigator will monitor the subjects at baseline, Month 1, and Month 3 visits, which will consist of patient questionnaires, blood sampling, and Adverse Events monitoring.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98431
      • Madigan Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 49 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Premenopausal women, 16 to 49 years of age
• Diagnosed with endometriosis by means of documented surgical visualization (laparoscopy or laparotomy) within 10 years of study entry
• No endometriosis-related surgical procedures within a month of starting study agent
• Has at least 2 days of moderate or severe pain scores for dysmenorrhea (E-diary NRS > 5 of 10) and non-menstrual pelvic pain (E-diary NRS > 5 of 10) during the month prior to starting study agent
• Must have had a menstrual cycle of interval 24-35 days within 3 months of starting study agent
• BMI 18 to 39
• Able to provide written informed consent and able to comply with study procedures for the entire length of the study

Exclusion Criteria:

• Pregnant or breastfeeding or planning pregnancy in the next 12 months
• Has been pregnant within 3 months of starting study agent
• Has had a hysterectomy or bilateral oophorectomy
• Has chronic pelvic pain not caused by endometriosis (i.e. inflammatory bowl disease, irritable bowel syndrome, adenomyosis, interstitial cystitis, pelvic adhesive disease, pelvic inflammatory disease) that requires chronic analgesic or narcotic use which would interfere with assessment of endometriosis associated pain
• Current history of undiagnosed abnormal uterine bleeding
• Currently receiving Gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or have received any of these types of medications within 6 months of starting study agent
• Currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or i.m. medroxyprogesterone acetate (DMPA-IM) or have received any of these within the last 3 months of enrollment
• Currently has an intrauterine device in place
• Use of steroids or immunosuppressive medications on a regular basis within 3 months of enrollment
• Has an unstable medical condition, chronic disease or psychiatric disorder that is deemed by the investigator to be incompatible with participation in the study
• Treatment with any other investigational drug/interventions within 3 months of starting study agent
• History of drug or alcohol abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Electro-kinetically Modified Water; Subjects will drink 2 to 3 500 mL bottles of EMW daily for 3 months	Other: Electro-kinetically Modified Water; Subjects assigned to this arm will receive the EMW
PLACEBO_COMPARATOR: Placebo; Subjects will drink 2 to 3 500 mL bottles of purified drinking water daily for 3 months	Other: Placebo; Purified Drinking Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in endometriosis symptoms using the Composite Pelvic Signs and Symptoms Scale (CPSSS) total composite score.	3 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in dysmenorrhea score on the CPSSS.	3 months
Change in non-menstrual pelvic pain score on the CPSSS.	3 month
Change in dyspareunia score on the CPSSS.	3 months
Change in premenstrual spotting from baseline on a numerical rating scale (NRS)	3 month
Change in use of rescue analgesia	3 months
Change in endometrioma size as measured by TVUS	3 months
Change in endometriosis symptoms using the Endometriosis Health Profile (EHP-30) questionnaire.	3 months

Collaborators and Investigators

• Sponsor: Revalesio Corporation
• Collaborators: The Geneva Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2015
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: August 6, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (ESTIMATE): August 14, 2015

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endometriosis; Pelvic Pain
• Other Study ID Numbers: 14.1.1.H1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No