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

NCT ID: NCT02523794

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-09-30

Brief Summary

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.

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.

Conditions

Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Electro-kinetically Modified Water

Subjects will drink 2 to 3 500 mL bottles of EMW daily for 3 months

Group Type: EXPERIMENTAL

Electro-kinetically Modified Water

Intervention Type: OTHER

Subjects assigned to this arm will receive the EMW

Placebo

Subjects will drink 2 to 3 500 mL bottles of purified drinking water daily for 3 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Purified Drinking Water

Interventions

Electro-kinetically Modified Water

Subjects assigned to this arm will receive the EMW

Intervention Type: OTHER

Placebo

Purified Drinking Water

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Geneva Foundation

OTHER

Sponsor Role: collaborator

Revalesio Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Madigan Army Medical Center

Tacoma, Washington, United States

Countries

United States

Other Identifiers

14.1.1.H1

Identifier Type: -

Identifier Source: org_study_id