Back to resultsEvaluation of Safety/Efficacy of Diagnostic Skin Test Panel and Desensitization Hormone Kit for Treatment of Premenstrual Syndrome (PMS)
Primary Purpose
Premenstrual Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Skin test panel and desensitization kit
Skin test panel and solvent
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Syndrome focused on measuring PreMenstrual Syndrome, Hormones, Skin tests, Desensitization, 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
- 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).
Sites / Locations
- Tel Aviv Sourasky Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Hormones
Solvent
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
To assess the efficacy of hormonal desensitization compared to solvent treatment in reduction of the breast swelling and tenderness in 4 weeks of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00873262
Brief Title
Evaluation of Safety/Efficacy of Diagnostic Skin Test Panel and Desensitization Hormone Kit for Treatment of Premenstrual Syndrome (PMS)
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
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) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
PreMenstrual Syndrome, Hormones, Skin tests, Desensitization, Allergen Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hormones
Arm Type
Active Comparator
Arm Title
Solvent
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Skin test panel and desensitization kit
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)
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:
Week 4th of the study (luteal phase of 2nd menstrual cycle) - 0.04 ml
Week 8th of the study (luteal phase of 3rd menstrual cycle) - 0.08 ml
Week 12th of the study (luteal phase of 4th menstrual cycle) - 0.16 ml
Intervention Type
Drug
Intervention Name(s)
Skin test panel and solvent
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)
Patients with positive skin test to at least one sex hormone will be injected with an increasing volume of the solvent as follows:
Week 4th of the study (luteal phase of 2nd menstrual cycle) - 0.04 ml
Week 8th of the study (luteal phase of 3rd menstrual cycle) - 0.08 ml
Week 12th of the study (luteal phase of 4th menstrual cycle) - 0.16 ml
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
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).
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
Shmuel Kivity, Prof.
Organizational Affiliation
Tel Aviv Sourasky Medical Center, Department of Allergy and clinical immunology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacob Cohen, Dr.
Organizational Affiliation
Tel Aviv Sourasky Medical Center, Department of Outpatient Gynecology Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shmuel Kivity, Prof.
Phone
+972-3-697-3734
Email
allergy@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Tzipi Yemini
Phone
+972-3-697-3734
Email
zipiy@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Shmuel Kivity, Prof.
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Safety/Efficacy of Diagnostic Skin Test Panel and Desensitization Hormone Kit for Treatment of Premenstrual Syndrome (PMS)
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