Back to resultsEvaluation of Efficacy/Safety of EVE-PMS Skin Test Panel
Primary Purpose
Premenstrual Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Skin test panel
Skin test panel
Sponsored by
About this trial
This is an interventional diagnostic trial for Premenstrual Syndrome focused on measuring PMS, Hormones, Skin tests, Allergen Immunotherapy
Eligibility Criteria
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:
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:
- Pregnant or lactating woman
- Oral contraceptives during last three months, including hormonal IUD (trade name mirena).
- Serious health problems.
- Unexplained menstrual disorders.
- Treated by hormones (estrogen and progesterone).
- For healthy: Irregular or abnormal test results.
Sites / Locations
- Sheba Medical Center, Tel-HashomerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy Control group
PMS
Arm Description
Outcomes
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
Secondary Outcome Measures
Minimal skin test related adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00866437
Brief Title
Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel
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 Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
EVE Medical Systems Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
PMS, Hormones, Skin tests, Allergen Immunotherapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Control group
Arm Type
Experimental
Arm Title
PMS
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Skin test panel
Other Intervention Name(s)
Progesterone, Estradiol, Estrone, Estriol
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Skin test panel
Other Intervention Name(s)
Progesterone, Estradiol, Estrone, Estriol
Intervention Description
Hormones:
Progesterone 1mmol/L
Estradiol 1 mmol/L
Estrone 3 mmol/L
Estriol 3mmol/l
Controls:
Saline (NaCl) 0.9%
Ethyl Oleate with 10% Benzyl Alcohol
Histamine phosphate 1mg/ml (epicutaneous- prick test)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Minimal skin test related adverse events.
Time Frame
2-3 Months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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:
Pregnant or lactating woman
Oral contraceptives during last three months, including hormonal IUD (trade name mirena).
Serious health problems.
Unexplained menstrual disorders.
Treated by hormones (estrogen and progesterone).
For healthy: Irregular or abnormal test results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yonit Bomstein, Dr.
Phone
+972-54-7889917
Email
ybomstein@evepms.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alek Itsekson, Dr.
Phone
+972-50-5622098
Email
itsekson@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avner Reshef, Dr.
Organizational Affiliation
Allergy and clinical Immunology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center, Tel-Hashomer
City
Ramat Efal
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avner Reshef, Dr
Phone
+972-3-5302605
Email
Avner.Reshef@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Iris Leibovich
Phone
+972-3-5302605
Email
iris.leibovich@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Avner Reshef, Dr
12. IPD Sharing Statement
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Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel
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