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The Effectiveness and Safety of LIVIA® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea.

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ClinicalTrials.gov Identifier: NCT03064945
Recruitment Status : Completed
First Posted : February 27, 2017
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
iPulse Medical Ltd. (Livia)

Tracking Information
First Submitted Date  ICMJE February 22, 2017
First Posted Date  ICMJE February 27, 2017
Last Update Posted Date May 1, 2018
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date April 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
The difference between the reported Visual Analogue Scale before and after applying the device (active or sham). [ Time Frame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. ]
Each participant will rank the severity of her dysmenorrhea symptoms before and after the device use on the VAS scale from 0 to 100, where 0 determines- "No pain" and 100 determines "Very painful". Then, the difference between the two measurements will be calculated.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
  • Usage of pain relievers during the menstrual period [ Time Frame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. ]
    Usage of pain relievers during the menstrual period as recorded in the subjects' diaries. This will be measured by the number of pain relief pills taken during the entire menstrual period
  • Quality of life [ Time Frame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. ]
    Quality of life will be assessed using the Q-LES Questionnaire. The summary score will be determined as per the questionnaire manual
  • The convenience of device operation [ Time Frame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. ]
    The convenience of device operation and usage will be determined using a series of specific questions posed to the subjects at visit 3.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 24, 2017)
SAFETY AND TOLERABILITY ENDPOINTS [ Time Frame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. ]
The safety and tolerability endpoints of this study are Adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the study Duration of device use
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effectiveness and Safety of LIVIA® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea.
Official Title  ICMJE A Randomized, Controlled, Multi-Center, CROSSOVER, Prospective, Double-blind Clinical Study to Assess the Effectiveness and Safety of Livia® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea
Brief Summary

This is a randomized, controlled, multi-center, single-arm, crossover, double-blind clinical study assessing the Livia Transcutaneous Electrical Nerve Stimulation (TENS) in women suffering from dysmenorrhea. The study will be conducted at community clinics. Advertisement will be used to publish and promote recruitment.

The study will include 3 visits: Screening visit and two consecutive visits each one after monthly menstrual period. Treatment will be self-administrated and during the study, the subjects will be requested to complete home diaries.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dysmenorrhea
Intervention  ICMJE Device: Livia
Livia® Transcutaneous Electrical Nerve Stimulation (TENS) is a novel pain management device for women suffering from dysmenorrhea
Study Arms  ICMJE
  • Sham Comparator: Shame device
    Intervention: Device: Livia
  • Experimental: Livia® Transcutaneous Electrical Nerve Stimulation (TENS)
    Intervention: Device: Livia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2017)
63
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 25, 2018
Actual Primary Completion Date April 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Women between the age 18 to 45 years
  2. Women reporting painful menstruation during the last 3 menstrual cycles.
  3. Pain VAS score of at least 60 based on previous menstrual cycle
  4. Subject is willing and able to comply with the study protocol and provide written informed consent to participate in the study.
  5. Subject must agree to consistently use effective contraception throughout the study. (Subject not treated with oral contraception should use any contraception other than oral).

Exclusion Criteria:

  1. Participation in any other investigational study within 30 days prior and/or at the date of subject consent.
  2. Woman with a significant medical condition such as: cancer, diabetes (Type I and II), irritable bowel disease IBD, immunodeficiency, autoimmune disease, etc. that in the investigator opinion, participation in the study would place the patient at an unacceptable risk.
  3. Pregnant woman
  4. A woman who is diagnosed with secondary dysmenorrhea associated with uterine myomas, endometriosis, adenomyosis, etc.
  5. A woman who has cardiac condition with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: This study on women that suffering from painful menstruation
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03064945
Other Study ID Numbers  ICMJE LIVIA-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party iPulse Medical Ltd. (Livia)
Study Sponsor  ICMJE iPulse Medical Ltd. (Livia)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account iPulse Medical Ltd. (Livia)
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP