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

Pelvic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02523794
• Other study ID #: 14.1.1.H1
• Status: Terminated
• Phase: N/A
• First received: August 6, 2015
• Last updated: January 23, 2018
• Start date: August 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2018
• Source: Revalesio Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

Other:
• Electro-kinetically Modified Water
Subjects assigned to this arm will receive the EMW
• Placebo
Purified Drinking Water

Locations

Country	Name	City	State
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Revalesio Corporation	The Geneva Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in endometriosis symptoms using the Composite Pelvic Signs and Symptoms Scale (CPSSS) total composite score.		3 Months
Secondary	Change in dysmenorrhea score on the CPSSS.		3 months
Secondary	Change in non-menstrual pelvic pain score on the CPSSS.		3 month
Secondary	Change in dyspareunia score on the CPSSS.		3 months
Secondary	Change in premenstrual spotting from baseline on a numerical rating scale (NRS)		3 month
Secondary	Change in use of rescue analgesia		3 months
Secondary	Change in endometrioma size as measured by TVUS		3 months
Secondary	Change in endometriosis symptoms using the Endometriosis Health Profile (EHP-30) questionnaire.		3 months