NCT02523794

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

August 6, 2015

Last Update Submit

January 23, 2018

Conditions

Pelvic Pain

Outcome Measures

Primary Outcomes (1)

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

    3 Months

Secondary Outcomes (7)

  • Change in dysmenorrhea score on the CPSSS.

    3 months

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

    3 month

  • Change in dyspareunia score on the CPSSS.

    3 months

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

    3 month

  • Change in use of rescue analgesia

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Electro-kinetically Modified Water

EXPERIMENTAL

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

Other: Electro-kinetically Modified Water

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Electro-kinetically Modified WaterOTHER

Subjects assigned to this arm will receive the EMW

Electro-kinetically Modified Water
PlaceboOTHER

Purified Drinking Water

Placebo

Eligibility Criteria

Age16 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 14, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

US(1)