A Randomized, Controlled, Multi-center, Crossover, Prospective, Double-blind Clinical Study To Assess The Effectiveness And Safety Of
In Women Suffering From Primary Dysmenorrhea
Safety and efficacy of Livia vs. Sham
non-stimulated device on Dysmenorrhea (painful menstruation) symptoms in menstruating women
Eligible subjects randomly assigned in a 1:1 ratio to one of 2 sequences:
Sequence A = Use of the Livia device during the first study cycle (Menstrual Period (MP)) and a sham device during the second study cycle.
Sequence B = Use of a sham device during the first study cycle and Livia device during the second study cycle.
PRIMARY EFFICACY ENDPOINT:
The primary efficacy endpoint of the study is to evaluate the difference between the reported Visual Analogue Scale (VAS) before and after applying the device (active or sham).
SAFETY AND TOLERABILITY ENDPOINTS:
The safety and tolerability endpoints of this study are:
Adverse events (AEs) and serious adverse events (SAEs)
Duration of use of the device
SECONDARY EFFICACY ENDPOINT:
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 will be assessed using the Q-LES Questionnaire. The summary score will be determined as per the questionnaire manual.
The convenience of device operation and usage will be determined using a series of specific questions posed to the subjects at visit 3.
Subjects in the study experienced a decline in pain as assessed by the Visual Analogue Scale (VAS).
The use of Livia device succeeded in reducing the VAS score by an average of 28.1 points.
The use of Sham device reduced the VAS score by 17.6 points.
A statistically significant difference between Livia and Sham was observed (P<0.0001).
Analysis of reduction in VAS was also carried out separately for each treatment sequence:
Livia caused a greater reduction in VAS in sequence A (first Livia, then sham)
Sham caused a greater reduction in VAS in sequence B (first sham, then Livia).
Therefore, statistically significant reduction in VAS was observed only in sequence A (P<0.0001) but not in the sequence B (P=0.3923).
Secondary analyses evaluated the use of pain relief pills, quality of life (QoL) and device usability.
Most subjects used pain relief pills once or twice per cycle in all treatments and treatment sequences.
The QoL score was higher in both sequence treatment groups compared to Baseline. The improvement in QoL was higher in sequence A (first Livia, then sham) compared to sequence B (first sham, then Livia).
Usability of the device received good scores by users and no technical problems were detected.