Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Diagnostic
|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 Premenstrual Syndrome|
- 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 ] [ Designated as safety issue: Yes ]
- Minimal skin test related adverse events. [ Time Frame: 2-3 Months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||November 2010|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
|Experimental: Healthy Control group||
Drug: Skin test panel
Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators.
Drug: Skin test panel
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866437
|Sheba Medical Center, Tel-Hashomer|
|Ramat Efal, Israel, 52621|
|Principal Investigator:||Avner Reshef, Dr.||Allergy and clinical Immunology Department|