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Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel
This study is currently recruiting participants.
Verified by EVE Medical Systems Ltd., March 2009
First Received: March 19, 2009   Last Updated: April 14, 2009   History of Changes
Sponsored by: EVE Medical Systems Ltd.
Information provided by: EVE Medical Systems Ltd.
ClinicalTrials.gov Identifier: NCT00866437
  Purpose

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.


Condition Intervention Phase
Premenstrual Syndrome
Drug: Skin test panel
Phase II

MedlinePlus related topics: Premenstrual Syndrome
Drug Information available for: Estriol Estradiol Estradiol 3-benzoate Estrone Progesterone Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate 16-Epiestriol Estradiol valerate Estradiol acetate Estropipate
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Single Blind (Caregiver), Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by EVE Medical Systems Ltd.:

Primary Outcome Measures:
  • EVE-PMS Skin-Test Panel can obtain statistically significant sensitivity & specificity to support the diagnosis of PMS, particularly in women with severe symptoms(i.e. breast swelling; tenderness; other PMS symptoms according to widely accepted criteria [ Time Frame: Total study duration will be approximately 2-3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Minimal skin test related adverse events. [ Time Frame: 2-3 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: April 2009
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Non-PMS: Experimental
Healthy Control group
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)
PMS: Experimental 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)

Detailed Description:

The study objectives are to evaluate the efficacy and safety of the EVE-PMS Skin-Test Panel to accurately detect sensitivity to sex hormones in PMS patients with leading symptoms (i.e. mastalgia), compared to normal control women.

A group of 20 healthy women age 20-45 (CONTROL group) and matched group of 20 women age 20-45 years attending PMS clinic (PMS group) will be enrolled in the study. The PMS group are having a clinical history of PMS, with a dominant severe clinical symptoms, such as breast swelling and tenderness (mastalgia). Subjects of both groups will be tested intradermally with 4 hormones and 3 control reagents.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Person is over the age of 20 but not older than age 45.
  2. Person is willing to participate as evidenced by signing the written informed consent form.
  3. Suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of PMS symptoms severity)
  4. 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.
  5. At work, school, home, or in daily routine, at least one of the PMS symptoms caused reduction of productivity or inefficiency
  6. At least one of the PMS symptoms caused avoidance of or less participation in hobbies or social activities
  7. At least one of the PMS symptoms interfere with relationships with others:

    i. Timing of PMS symptom(s): during the 14 days prior to onset of menstrual flow (rather than spotting) and up to 5 days during the menstrual flow. ii. Pattern and length of PMS symptomatic period: minimum of 2 days, up to 14 days.

iii. For PMS diagnosis two out of last three consecutive menstrual cycles were monitored by daily monitoring of symptoms.

iv. Timing and length of asymptomatic phase: day 6 to at least day 10 of the menstrual cycle.

v. Cyclicity - presentation of the 'off-on' phenomenon: there should be a clear shift from no PMS symptoms to PMS symptoms.

vi. Reliable non hormonal contraception.

Exclusion Criteria:

  1. Pregnant or lactating woman
  2. Oral contraceptives during last three months, including hormonal IUD (trade name mirena).
  3. Serious health problems.
  4. Unexplained menstrual disorders.
  5. Treated by hormones (estrogen and progesterone).
  6. For healthy: Irregular or abnormal test results.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866437

Contacts
Contact: Yonit Bomstein, Dr. +972-54-7889917 ybomstein@evepms.com
Contact: Alek Itsekson, Dr. +972-50-5622098 itsekson@netvision.net.il

Locations
Israel
Sheba Medical Center, Tel-Hashomer Recruiting
Ramat Efal, Israel, 52621
Contact: Avner Reshef, Dr     +972-3-5302605     Avner.Reshef@sheba.health.gov.il    
Contact: Iris Leibovich     +972-3-5302605     iris.leibovich@sheba.health.gov.il    
Principal Investigator: Avner Reshef, Dr            
Sponsors and Collaborators
EVE Medical Systems Ltd.
Investigators
Principal Investigator: Avner Reshef, Dr. Allergy and clinical Immunology Department
  More Information

No publications provided

Responsible Party: EVE Medical Systems Ltd. ( Dr. Yonit Bomstein )
Study ID Numbers: EveMS-0908
Study First Received: March 19, 2009
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00866437     History of Changes
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by EVE Medical Systems Ltd.:
PMS
Hormones
Skin tests
Allergen Immunotherapy

Study placed in the following topic categories:
Estrogens
Progesterone
Hormone Antagonists
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Estradiol 17 beta-cypionate
Hormones
Estradiol
Histamine
Menstruation Disturbances
Progestins
Estradiol 3-benzoate
Histamine phosphate
Polyestradiol phosphate
Premenstrual Syndrome
Ethanol
Estrone

Additional relevant MeSH terms:
Estrogens
Disease
Progesterone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Estradiol
Pharmacologic Actions
Pathologic Processes
Menstruation Disturbances
Progestins
Syndrome
Premenstrual Syndrome
Estrone

ClinicalTrials.gov processed this record on May 07, 2009