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Trial record 5 of 23 for:    Estropipate

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE March 19, 2009
First Posted Date  ICMJE March 20, 2009
Last Update Posted Date June 16, 2010
Study Start Date  ICMJE April 2009
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00866437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2009)
Minimal skin test related adverse events. [ Time Frame: 2-3 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Condition  ICMJE Premenstrual Syndrome
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Healthy Control group
    Intervention: Drug: Skin test panel
  • Experimental: PMS
    Intervention: Drug: Skin test panel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 19, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2010
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00866437
Other Study ID Numbers  ICMJE EveMS-0908
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Yonit Bomstein, EVE Medical Systems Ltd.
Study Sponsor  ICMJE EVE Medical Systems Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Avner Reshef, Dr. Allergy and clinical Immunology Department
PRS Account EVE Medical Systems Ltd.
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP