NCT03064945

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: iPulse Medical Ltd. (Livia) · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-04-25
• Completion: 2018-04-25
• First posted: 2017-02-27
• Last updated: 2018-05-01

Locations

1 site across 1 country: Israel