NCT00866437

Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: EVE Medical Systems Ltd. · Industry
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Premenstrual Syndrome

Interventions

Type	Name	Description
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. Hormones: 1. Progesterone 1mmol/L 2. Estradiol 1mmol/L 3. Estrone 3mmol/L 4. Estriol 3mmol/l Controls: 5. Saline (NaCl) 0.9% 6. Ethyl Oleate with 10% Benzyl Alcohol 7. Histamine phosphate 1mg/ml (epicutaneous- prick test)
DRUG	Skin test panel	Hormones: 1. Progesterone 1mmol/L 2. Estradiol 1 mmol/L 3. Estrone 3 mmol/L 4. Estriol 3mmol/l Controls: 5. Saline (NaCl) 0.9% 6. Ethyl Oleate with 10% Benzyl Alcohol 7. Histamine phosphate 1mg/ml (epicutaneous- prick test)

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-05-01
• Completion: 2010-11-01
• First posted: 2009-03-20
• Last updated: 2010-06-16

Locations

1 site across 1 country: Israel