Clinical Trial: Evaluation of Safety/Efficacy of Diagnostic Skin Test Panel and Desensitization Hormone Kit for Treatment of Premenstrual Syndrome (PMS)

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

Official Title: A Phase II Randomized, Two-arms, Single-blind, Cross Controlled Study for Evaluation the Safety and Efficacy of Diagnosis and Treatment of Premenstrual Syndrome by Detecti

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) and desensitizes them with the relevant sex hormones in order to reduce PMS symptoms.

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 eligibility of the patients to enter a desensitization protocol.

During the desensitization period hormones to which the patient were found sensitive to, are injected intradermally three times (once a month) within the luteal phase in increasing doses. The end-point of the study is a statistically significant decrease, or elimination of PMS symptoms, compared to a solvent group.

Detailed Summary:
Sponsor: EVE Medical Systems Ltd.

Current Primary Outcome: To assess the efficacy of hormonal desensitization compared to solvent treatment in reduction of the PMS symptoms severity and length of PMS by subjects with severe PMS symptoms (according to criteria of PMS). [ Time Frame: 5-6 months ]

Original Primary Outcome: To assess the efficacy of hormonal desensitization compared to solvent treatment in reduction of the PMS symptoms severity and duration of PMS by subjects with severe PMS symptoms (according to criteria of PMS). [ Time Frame: 5-6 months ]

Current Secondary Outcome: To assess the efficacy of hormonal desensitization compared to solvent treatment in reduction of the breast swelling and tenderness in 4 weeks of treatment. [ Time Frame: 2-3 months ]

Original Secondary Outcome: Same as current

Information By: EVE Medical Systems Ltd.

Dates:
Date Received: March 30, 2009
Date Started: April 2009
Date Completion: November 2010
Last Updated: June 15, 2010
Last Verified: February 2010