Clinical Trial: Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prospective, Controlled, Single-blinded, Longitudinal, Two-arms, Clinical Study Evaluation of Efficacy/Safety of EVE-PMS Skin-Test Panel -Detecting Sensitivity to Sex Hormones in Women With

Brief Summary:

The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS).

The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the value of EVE-PMS Skin-Test Panel as a diagnostic tool for severe PMS patients.

Detailed Summary:
Sponsor: EVE Medical Systems Ltd.

Current Primary Outcome: EVE-PMS Skin-Test Panel can obtain statistically significant sensitivity & specificity to support the diagnosis of PMS, particularly in women with severe symptoms(i.e. breast swelling; tenderness; other PMS symptoms according to widely accepted criteria [ Time Frame: Total study duration will be approximately 2-3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Minimal skin test related adverse events. [ Time Frame: 2-3 Months ]

Original Secondary Outcome: Same as current

Information By: EVE Medical Systems Ltd.

Dates:
Date Received: March 19, 2009
Date Started: April 2009
Date Completion: November 2010
Last Updated: June 15, 2010
Last Verified: February 2010