Clinical trial NCT03064945: The Effectiveness and Safety of LIVIA® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dysmenorrhea
Keywords: Livia TENS
safety and efficacy
menstruating women
Lead sponsor: iPulse Medical Ltd. (Livia)
Sponsor class: INDUSTRY
First posted: 2017-02-27
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The difference between the reported Visual Analogue Scale before and after applying the device (active or sham).
timeFrame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
Secondary outcomes:
measure: Usage of pain relievers during the menstrual period
timeFrame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
measure: Quality of life
timeFrame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
measure: The convenience of device operation
timeFrame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
Other outcomes:
measure: SAFETY AND TOLERABILITY ENDPOINTS
timeFrame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
Locations:
city: Jerusalem
country: Israel
facility: Hadassah
Study officials:
References: