Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel
Recruitment status was Recruiting
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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 |
- 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 ]
- 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:
Other Names:
|
| Experimental: PMS |
Drug: Skin test panel
Hormones:
Other Names:
|
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Yonit Bomstein, Dr. | +972-54-7889917 | ybomstein@evepms.com |
| Contact: Alek Itsekson, Dr. | +972-50-5622098 | itsekson@netvision.net.il |
| 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 | |
| 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 May 22, 2013