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

PHASE2UnknownINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

May 31, 2010

Study Completion Date

November 30, 2010

Conditions
Premenstrual Syndrome
Interventions
DRUG

Skin test panel and desensitization kit

"Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators.~Hormones:~Progesterone 1mmol/L; Estradiol 1mmol/L; Estrone 3mmol/L; Estriol 3mmol/L~Controls:~Saline (NaCl) 0.9%; Ethyl Oleate with 10% Benzyl Alcohol; Histamine phosphate 1mg/ml (epicutaneous- prick test)~Patients with positive skin test to at least one sex hormone will be injected with an increasing volume of the appropriate hormone at the same concentration as it was used in the skin test as follows:~1. Week 4th of the study (luteal phase of 2nd menstrual cycle) - 0.04 ml~2. Week 8th of the study (luteal phase of 3rd menstrual cycle) - 0.08 ml~3. Week 12th of the study (luteal phase of 4th menstrual cycle) - 0.16 ml"

DRUG

Skin test panel and solvent

"Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators.~Hormones:~Progesterone 1mmol/L; Estradiol 1mmol/L; Estrone 3mmol/L; Estriol 3mmol/L~Controls:~Saline (NaCl) 0.9%; Ethyl Oleate with 10% Benzyl Alcohol; Histamine phosphate 1mg/ml (epicutaneous- prick test)~Patients with positive skin test to at least one sex hormone will be injected with an increasing volume of the solvent as follows:~1. Week 4th of the study (luteal phase of 2nd menstrual cycle) - 0.04 ml~2. Week 8th of the study (luteal phase of 3rd menstrual cycle) - 0.08 ml~3. Week 12th of the study (luteal phase of 4th menstrual cycle) - 0.16 ml"

Trial Locations (1)

64239

RECRUITING

Tel Aviv Sourasky Medical Center, Tel Aviv

Sponsors
All Listed Sponsors
lead

EVE Medical Systems Ltd.

INDUSTRY