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

NCT03064945 | Completed Phase 2 DMC

• 1 other identifier: LIVIA-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea

Keywords

Livia TENS; safety and efficacy; menstruating women

Outcome Measures

Primary Outcomes (1)

• The difference between the reported Visual Analogue Scale before and after applying the device (active or sham).

  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.

  3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.

Secondary Outcomes (3)

• Usage of pain relievers during the menstrual period

  3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.

• Quality of life

  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

  3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.

Other Outcomes (1)

• SAFETY AND TOLERABILITY ENDPOINTS

  3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.

Study Arms (2)

Shame device

SHAM COMPARATOR

Device: Livia

Livia® Transcutaneous Electrical Nerve Stimulation (TENS)

EXPERIMENTAL

Device: Livia

Interventions

Livia DEVICE

Livia® Transcutaneous Electrical Nerve Stimulation (TENS) is a novel pain management device for women suffering from dysmenorrhea

Livia® Transcutaneous Electrical Nerve Stimulation (TENS); Shame device

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: This study on women that suffering from painful menstruation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Participation in any other investigational study within 30 days prior and/or at the date of subject consent.
• 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.
• Pregnant woman
• A woman who is diagnosed with secondary dysmenorrhea associated with uterine myomas, endometriosis, adenomyosis, etc.
• A woman who has cardiac condition with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.

Sponsors & Collaborators

• iPulse Medical Ltd. (Livia): lead

Study Sites (1)

Hadassah

Jerusalem, Israel

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 27, 2017
• Study Start: June 1, 2017
• Primary Completion: April 25, 2018
• Study Completion: April 25, 2018
• Last Updated: May 1, 2018

Record last verified: 2017-05

Locations

IL (1)