Evaluation of Safety/Efficacy of Diagnostic Skin Test Panel and Desensitization Hormone Kit for Treatment of Premenstrual Syndrome (PMS)
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) and desensitizes them with the relevant sex hormones in order to reduce PMS symptoms.
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 eligibility of the patients to enter a desensitization protocol.
During the desensitization period hormones to which the patient were found sensitive to, are injected intradermally three times (once a month) within the luteal phase in increasing doses. The end-point of the study is a statistically significant decrease, or elimination of PMS symptoms, compared to a solvent group.
| Condition | Intervention | Phase |
|---|---|---|
|
Premenstrual Syndrome |
Drug: Skin test panel and desensitization kit Drug: Skin test panel and solvent |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Phase II Randomized, Two-arms, Single-blind, Cross Controlled Study for Evaluation the Safety and Efficacy of Diagnosis and Treatment of Premenstrual Syndrome by Detecting Skin Reactions Followed by Desensitization to Sex Hormones |
- To assess the efficacy of hormonal desensitization compared to solvent treatment in reduction of the PMS symptoms severity and length of PMS by subjects with severe PMS symptoms (according to criteria of PMS). [ Time Frame: 5-6 months ] [ Designated as safety issue: Yes ]
- To assess the efficacy of hormonal desensitization compared to solvent treatment in reduction of the breast swelling and tenderness in 4 weeks of treatment. [ Time Frame: 2-3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| 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 |
|---|---|
| Active Comparator: Hormones |
Drug: Skin test panel and desensitization kit
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) Patients with positive skin test to at least one sex hormone will be injected with an increasing volume of the appropriate hormone at the same concentration as it was used in the skin test as follows:
Other Names:
|
| Placebo Comparator: Solvent |
Drug: Skin test panel and solvent
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) Patients with positive skin test to at least one sex hormone will be injected with an increasing volume of the solvent as follows:
Other Names:
|
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
- 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.
- Pattern and length of PMS symptomatic period: minimum of 2 days, up to 14 days.
- For PMS diagnosis two out of last three consecutive menstrual cycles were monitored by daily monitoring of symptoms.
- Timing and length of asymptomatic phase: day 6 to at least day 10 of the menstrual cycle.
- Cyclicity - presentation of the 'off-on' phenomenon: there should be a clear shift from no PMS symptoms to PMS symptoms.
- 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).
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 | |
| Tel Aviv Sourasky Medical Center | Recruiting |
| Tel Aviv, Israel, 64239 | |
| Contact: Shmuel Kivity, Prof. +972-3-697-3734 allergy@tasmc.health.gov.il | |
| Contact: Tzipi Yemini +972-3-697-3734 zipiy@tasmc.health.gov.il | |
| Principal Investigator: Shmuel Kivity, Prof. | |
| Principal Investigator: | Shmuel Kivity, Prof. | Tel Aviv Sourasky Medical Center, Department of Allergy and clinical immunology |
| Principal Investigator: | Jacob Cohen, Dr. | Tel Aviv Sourasky Medical Center, Department of Outpatient Gynecology Clinics |
More Information
No publications provided
| Responsible Party: | Dr. Yonit Bomstein, EVE Medical Systems Ltd. |
| ClinicalTrials.gov Identifier: | NCT00873262 History of Changes |
| Other Study ID Numbers: | EVE-2008-03 |
| Study First Received: | March 30, 2009 |
| Last Updated: | June 15, 2010 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by EVE Medical Systems Ltd.:
|
PreMenstrual Syndrome Hormones Skin tests Desensitization 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 19, 2013