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

Revalesio Corporation9 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pelvic Pain

Interventions

Electro-kinetically Modified WaterOTHER

Subjects assigned to this arm will receive the EMW

PlaceboOTHER

Purified Drinking Water

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 49 Years

Medical Language ↔ Plain English

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

Locations (1)

Madigan Army Medical Center

Tacoma, Washington, United States

Outcomes

Primary Outcomes

Change in endometriosis symptoms using the Composite Pelvic Signs and Symptoms Scale (CPSSS) total composite score.

Time frame: 3 Months

Secondary Outcomes

Change in dysmenorrhea score on the CPSSS.

Time frame: 3 months

Change in non-menstrual pelvic pain score on the CPSSS.

Time frame: 3 month

Change in dyspareunia score on the CPSSS.

Time frame: 3 months

Change in premenstrual spotting from baseline on a numerical rating scale (NRS)

Time frame: 3 month

Change in use of rescue analgesia

Time frame: 3 months

Change in endometrioma size as measured by TVUS

Time frame: 3 months

Change in endometriosis symptoms using the Endometriosis Health Profile (EHP-30) questionnaire.

Time frame: 3 months

Data from ClinicalTrials.gov

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