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

Primary Purpose

Pelvic Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electro-kinetically Modified Water
Placebo
Sponsored by
Revalesio Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain

Eligibility Criteria

16 Years - 49 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Electro-kinetically Modified Water

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in dysmenorrhea score on the CPSSS.
Change in non-menstrual pelvic pain score on the CPSSS.
Change in dyspareunia score on the CPSSS.
Change in premenstrual spotting from baseline on a numerical rating scale (NRS)
Change in use of rescue analgesia
Change in endometrioma size as measured by TVUS
Change in endometriosis symptoms using the Endometriosis Health Profile (EHP-30) questionnaire.

Full Information

First Posted
August 6, 2015
Last Updated
January 23, 2018
Sponsor
Revalesio Corporation
Collaborators
The Geneva Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02523794
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
August 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Revalesio Corporation
Collaborators
The Geneva Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electro-kinetically Modified Water
Arm Type
Experimental
Arm Description
Subjects will drink 2 to 3 500 mL bottles of EMW daily for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will drink 2 to 3 500 mL bottles of purified drinking water daily for 3 months
Intervention Type
Other
Intervention Name(s)
Electro-kinetically Modified Water
Intervention Description
Subjects assigned to this arm will receive the EMW
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Purified Drinking Water
Primary Outcome Measure Information:
Title
Change in endometriosis symptoms using the Composite Pelvic Signs and Symptoms Scale (CPSSS) total composite score.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Change in dysmenorrhea score on the CPSSS.
Time Frame
3 months
Title
Change in non-menstrual pelvic pain score on the CPSSS.
Time Frame
3 month
Title
Change in dyspareunia score on the CPSSS.
Time Frame
3 months
Title
Change in premenstrual spotting from baseline on a numerical rating scale (NRS)
Time Frame
3 month
Title
Change in use of rescue analgesia
Time Frame
3 months
Title
Change in endometrioma size as measured by TVUS
Time Frame
3 months
Title
Change in endometriosis symptoms using the Endometriosis Health Profile (EHP-30) questionnaire.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

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

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