Professionals

A first study was carried out on an early prototype of the Livia instrument:

- 61 women participated in this study.
All said they had suffered from painful menstrual cycles.
They were closely monitored during 4 consecutive menstrual cycles:

- During the first 2 menstrual cycles, no instrument was used. All women assessed the level of pain felt (1 to 10) and its location.

- During the next 2 cycles, the Livia prototype was used. All women reassessed the level of pain felt (1 to 10) and its location.

- After the 4 cycles, the data were analyzed and the following positive results were observed in a statistically robust manner:

Conclusion: the instrument relieves menstrual pain for 90% of women tested

- 31% said they were relieved completely

- 59% said they were moderately relieved

- 10% said they had little or no relief

32% of women reported that the instrument relieves pain significantly faster than common medications.

A second clinical study was conducted on an improved prototype of the Livia instrument:

102 women participated in this study. All declared having painful menstrual cycles. They were closely monitored during 4 menstrual cycles:

- During the first 2 cycles, no instrument was used. All women assessed the level of pain experienced (1 to 10) and the pain location.

- In the next 2 cycles, the Livia prototype was used. All women reassessed the level of pain felt (1 to 10) and its location.

- After the 4 cycles, the data were analyzed and the following positive results were observed in a statistically robust manner:

Conclusion: the instrument relieves menstrual pain for 86% of the women tested.

- 57% said they were relieved completely of any pain (compared to 31% with the first prototype as in Study #1)

-30% said they were moderately relieved of pain.

- 13% reported little or no relief.

Therefore the improvements in the instrument have significantly increased the proportion of women who experienced relief. 72.5% of women reported that the instrument relieves significantly faster than common drugs (compared to 32% in Study #1). The improvements that were made in the instrument have significantly increased the speed of action of the instrument.

A third study was conducted in order to validate the effectiveness and safety of the Livia instrument that is currently sold to the market.

- Conducted in 4 geographically different study sites.

- Conducted by 4 different study managers.

- Conducted on 65 randomly chosen women, divided into 2 groups.

Group A used Livia during their first menstrual cycle and a dummy instrument during their second cycle.
Group B used a dummy instrument during their first cycle and Livia during their second cycle.

Each of the women visited the study centers three times:

Visit number 1:

Establish the women's pain levels during their period (1-10), and to evaluate their perceived quality of life levels.

Visit number 2:

a. Establish the women's pain levels during their menses (1-10) while using either Livia or the dummy instrument.
b. Evaluate the women's perceived quality of life levels. c. Inquire regarding the use either of the Livia instrument or the dummy instrument.

Conclusion:

- The use of Livia during menstruation significantly reduces menstrual pain.

- The use of Livia reduced by an average of 28.1 points the perceived level of pain (Visual Analogue Scale (VAS) score).

- A statistically significant difference between the use of Livia and the use of the dummy apparatus was observed (P < 0.0001).

- Women observed an improvement in their quality of life levels when using Livia.

- Women appreciated Livia’s ease of use and the sense of security it generates.

i Rabin Hospital at the Beilinson Medical Center- Hasharon, Israel
ii TechnoStat, Data Management and Biostatistics Company, Israel