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TerminatedNCT02523794Updated Jan 25, 2018

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

An interventional study of Electro-kinetically Modified Water and Placebo in Pelvic Pain, sponsored by Revalesio Corporation. Terminated at 1 site in United States. Open to female participants aged 16 Years to 49 Years. Per ClinicalTrials.gov, last updated 2018-01-25.

Sponsored by Revalesio Corporation · Not applicable, Interventional, and Treatment

Why this study was terminated
Slow enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
16 Years to 49 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pelvic Pain
03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 9 is below the median of 64 across 525 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Revalesio Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Electro-kinetically Modified Water

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

    Other: Electro-kinetically Modified Water

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • OtherElectro-kinetically Modified Water

    Subjects assigned to this arm will receive the EMW

  • OtherPlacebo

    Purified Drinking Water

06

What researchers measure

Primary outcomes

  1. Change in endometriosis symptoms using the Composite Pelvic Signs and Symptoms Scale (CPSSS) total composite score.

    Time frame: 3 Months

Secondary outcomes

  1. Change in dysmenorrhea score on the CPSSS.

    Time frame: 3 months

  2. Change in non-menstrual pelvic pain score on the CPSSS.

    Time frame: 3 month

  3. Change in dyspareunia score on the CPSSS.

    Time frame: 3 months

  4. Change in premenstrual spotting from baseline on a numerical rating scale (NRS)

    Time frame: 3 month

  5. Change in use of rescue analgesia

    Time frame: 3 months

  6. Change in endometrioma size as measured by TVUS

    Time frame: 3 months

  7. Change in endometriosis symptoms using the Endometriosis Health Profile (EHP-30) questionnaire.

    Time frame: 3 months

07

Study locations

1 site
  • Madigan Army Medical Center
    Tacoma, Washington 98431, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02523794
Lead sponsor
Revalesio Corporation
Collaborators
The Geneva Foundation
Responsible party
Sponsor
First posted
Aug 14, 2015
Start date
Aug 2015
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Jan 25, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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