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

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.

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

Sponsors & Collaborators

• EVE Medical Systems Ltd.

  lead INDUSTRY

Principal Investigators

• Shmuel Kivity, Prof. · Tel Aviv Sourasky Medical Center, Department of Allergy and clinical immunology

• Jacob Cohen, Dr. · Tel Aviv Sourasky Medical Center, Department of Outpatient Gynecology Clinics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2010-05-31

Completion

2010-11-30

Countries

• Israel

Study Locations