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

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ClinicalTrials.gov Identifier: NCT00866437
Recruitment Status : Unknown
Verified February 2010 by EVE Medical Systems Ltd..
Recruitment status was:  Recruiting
First Posted : March 20, 2009
Last Update Posted : June 16, 2010
Sponsor:
Information provided by:
EVE Medical Systems Ltd.

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Premenstrual Syndrome Drug: Skin test panel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
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
Study Start Date : April 2009
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)
Other Names:
  • Progesterone
  • Estradiol
  • Estrone
  • Estriol
Experimental: PMS 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)
Other Names:
  • Progesterone
  • Estradiol
  • Estrone
  • Estriol


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Minimal skin test related adverse events. [ Time Frame: 2-3 Months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866437


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

Locations
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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
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Principal Investigator: Avner Reshef, Dr. Allergy and clinical Immunology Department
More Information
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Additional Information:
EVE's technology  This link exits the ClinicalTrials.gov site

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Responsible Party: Dr. Yonit Bomstein, EVE Medical Systems Ltd.
ClinicalTrials.gov Identifier: NCT00866437     History of Changes
Other Study ID Numbers: EveMS-0908
First Posted: March 20, 2009    Key Record Dates
Last Update Posted: June 16, 2010
Last Verified: February 2010
Keywords provided by EVE Medical Systems Ltd.:
PMS
Hormones
Skin tests
Allergen Immunotherapy
Additional relevant MeSH terms:
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Estropipate
Estrone
Syndrome
Premenstrual Syndrome
Disease
Pathologic Processes
Menstruation Disturbances
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Hormones
 Estradiol
Polyestradiol phosphate
Progesterone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins