Clinical trial NCT02523794: Study of Electro-kinetically Modified Water for the Treatment of Pain Associated With Endometriosis
Official title: A Double Blind, Placebo-controlled Study Evaluating an Electro-kinetically Modified Water for the Treatment of Pain Associated With Endometriosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pelvic Pain
Lead sponsor: Revalesio Corporation
Sponsor class: INDUSTRY
Collaborators: name: The Geneva Foundation
First posted: 2015-08-14
Enrollment: 9
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in endometriosis symptoms using the Composite Pelvic Signs and Symptoms Scale (CPSSS) total composite score.
timeFrame: 3 Months
Secondary outcomes:
measure: Change in dysmenorrhea score on the CPSSS.
timeFrame: 3 months
measure: Change in non-menstrual pelvic pain score on the CPSSS.
timeFrame: 3 month
measure: Change in dyspareunia score on the CPSSS.
timeFrame: 3 months
measure: Change in premenstrual spotting from baseline on a numerical rating scale (NRS)
timeFrame: 3 month
measure: Change in use of rescue analgesia
timeFrame: 3 months
measure: Change in endometrioma size as measured by TVUS
timeFrame: 3 months
measure: Change in endometriosis symptoms using the Endometriosis Health Profile (EHP-30) questionnaire.
timeFrame: 3 months
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
References: