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Sponsored by: |
EVE Medical Systems Ltd. |
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Information provided by: | EVE Medical Systems Ltd. |
ClinicalTrials.gov Identifier: | NCT00866437 |
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 II |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind (Caregiver), Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Non-PMS: 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:
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PMS: Experimental |
Drug: Skin test panel
Hormones:
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The study objectives are to evaluate the efficacy and safety of the EVE-PMS Skin-Test Panel to accurately detect sensitivity to sex hormones in PMS patients with leading symptoms (i.e. mastalgia), compared to normal control women.
A group of 20 healthy women age 20-45 (CONTROL group) and matched group of 20 women age 20-45 years attending PMS clinic (PMS group) will be enrolled in the study. The PMS group are having a clinical history of PMS, with a dominant severe clinical symptoms, such as breast swelling and tenderness (mastalgia). Subjects of both groups will be tested intradermally with 4 hormones and 3 control reagents.
Ages Eligible for Study: | 20 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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:
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 |
Responsible Party: | EVE Medical Systems Ltd. ( Dr. Yonit Bomstein ) |
Study ID Numbers: | EveMS-0908 |
Study First Received: | March 19, 2009 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00866437 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
PMS Hormones Skin tests Allergen Immunotherapy |
Estrogens Progesterone Hormone Antagonists Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists Estradiol 17 beta-cypionate Hormones Estradiol Histamine |
Menstruation Disturbances Progestins Estradiol 3-benzoate Histamine phosphate Polyestradiol phosphate Premenstrual Syndrome Ethanol Estrone |
Estrogens Disease Progesterone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Estradiol |
Pharmacologic Actions Pathologic Processes Menstruation Disturbances Progestins Syndrome Premenstrual Syndrome Estrone |