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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by EVE Medical Systems Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
EVE Medical Systems Ltd.
ClinicalTrials.gov Identifier:
NCT00866437
First received: March 19, 2009
Last updated: June 15, 2010
Last verified: February 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:


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: November 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Dr. Yonit Bomstein, EVE Medical Systems Ltd.
ClinicalTrials.gov Identifier: NCT00866437     History of Changes
Other Study ID Numbers: EveMS-0908
Study First Received: March 19, 2009
Last Updated: June 15, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Estradiol
Polyestradiol phosphate
Estrone
Hormones
Progesterone
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Progestins

ClinicalTrials.gov processed this record on July 28, 2014