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

iPulse Medical

Status and phase: Completed; Phase 2

Conditions: Dysmenorrhea

Treatments: Device: Livia

Study type: Interventional

Funder types: Industry

Identifiers

NCT03064945

LIVIA-01

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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63 participants in 2 patient groups

Shame device

Sham Comparator group

Treatment:

Device: Livia

Livia® Transcutaneous Electrical Nerve Stimulation (TENS)

Experimental group

Treatment:

Device: Livia