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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hormones | Active Comparator |
| |
| Solvent | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin test panel and desensitization kit | Drug | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 5-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of hormonal desensitization compared to solvent treatment in reduction of the breast swelling and tenderness in 4 weeks of treatment. | 2-3 months |
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Inclusion Criteria:
Person is over the age of 20 but not older than age 45.
Person is willing to participate as evidenced by signing the written informed consent form.
Suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of PMS symptoms severity)
Other severe symptoms of Premenstrual syndrome (based on WHO and ACOG criteria). This may include one or more of PMS symptoms with level 7-10 according to standard scale of PMS symptoms severity.
At work, school, home, or in daily routine, at least one of the PMS symptoms caused reduction of productivity or inefficiency
At least one of the PMS symptoms caused avoidance of or less participation in hobbies or social activities
At least one of the PMS symptoms interfere with relationships with others
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yonit Bomstein, Dr. | Contact | +972-54-7889917 | ybomstein@evepms.com | |
| Alek Itsekson, Dr. | Contact | +972-50-5622098 | itsekson@netvision.net.il |
| Name | Affiliation | Role |
|---|---|---|
| Shmuel Kivity, Prof. | Tel Aviv Sourasky Medical Center, Department of Allergy and clinical immunology | Principal Investigator |
| Jacob Cohen, Dr. | Tel Aviv Sourasky Medical Center, Department of Outpatient Gynecology Clinics |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 64239 | Israel |
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|
| Skin test panel and solvent | Drug | 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:
|
|
|
| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| D004958 | Estradiol |
| D004970 | Estrone |
| D004964 | Estriol |
| D012997 | Solvents |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D004963 | Estrenes |
| D004962 | Estranes |
| D045166 | Estradiol Congeners |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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