Premenstrual Syndrome Clinical Trial
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 Detecting Skin Reactions Followed by Desensitization to Sex Hormones
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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