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

Revalesio

Status

Terminated

Conditions

Pelvic Pain

Treatments

Other: Electro-kinetically Modified Water

Other: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02523794

14.1.1.H1

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

Female

Ages

16 to 49 years old

Volunteers

No Healthy Volunteers

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