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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Pelvic Pain

In brief

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.

Key facts

Study ID

NCT02523794

Run by

Revalesio Corporation

People needed

9

Starts

2015-08-01

Expected to finish

2016-09-01

Last updated by the study team

2018-01-25

Who can join

Age: 16 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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