Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel
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|ClinicalTrials.gov Identifier: NCT00866437|
Recruitment Status : Unknown
Verified February 2010 by EVE Medical Systems Ltd..
Recruitment status was: Recruiting
First Posted : March 20, 2009
Last Update Posted : June 16, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Premenstrual Syndrome||Drug: Skin test panel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Care Provider)|
|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|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||May 2010|
|Estimated Study Completion Date :||November 2010|
|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
- 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 ]
- Minimal skin test related adverse events. [ Time Frame: 2-3 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866437
|Contact: Yonit Bomstein, Dr.||+firstname.lastname@example.org|
|Contact: Alek Itsekson, Dr.||+email@example.com|
|Sheba Medical Center, Tel-Hashomer||Recruiting|
|Ramat Efal, Israel, 52621|
|Contact: Avner Reshef, Dr +972-3-5302605 Avner.Reshef@sheba.health.gov.il|
|Contact: Iris Leibovich +972-3-5302605 firstname.lastname@example.org|
|Principal Investigator: Avner Reshef, Dr|
|Principal Investigator:||Avner Reshef, Dr.||Allergy and clinical Immunology Department|