Evaluation of Safety/Efficacy of Diagnostic Skin Test Panel and Desensitization Hormone Kit for Treatment of Premenstrual Syndrome (PMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by EVE Medical Systems Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
EVE Medical Systems Ltd.
ClinicalTrials.gov Identifier:
NCT00873262
First received: March 30, 2009
Last updated: June 15, 2010
Last verified: February 2010
  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

Resource links provided by NLM:


Further study details as provided by EVE Medical Systems Ltd.:

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). [ Time Frame: 5-6 months ] [ Designated as safety issue: Yes ]

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. [ 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:

  1. Week 4th of the study (luteal phase of 2nd menstrual cycle) - 0.04 ml
  2. Week 8th of the study (luteal phase of 3rd menstrual cycle) - 0.08 ml
  3. Week 12th of the study (luteal phase of 4th menstrual cycle) - 0.16 ml
Other Names:
  • Progesterone
  • Estradiol
  • Estrone
  • Estriol
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:

  1. Week 4th of the study (luteal phase of 2nd menstrual cycle) - 0.04 ml
  2. Week 8th of the study (luteal phase of 3rd menstrual cycle) - 0.08 ml
  3. Week 12th of the study (luteal phase of 4th menstrual cycle) - 0.16 ml
Other Names:
  • Progesterone
  • Estradiol
  • Estrone
  • Estriol

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Person is over the age of 20 but not older than age 45.
  2. Person is willing to participate as evidenced by signing the written informed consent form.
  3. Suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of PMS symptoms severity)
  4. 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.
  5. At work, school, home, or in daily routine, at least one of the PMS symptoms caused reduction of productivity or inefficiency
  6. At least one of the PMS symptoms caused avoidance of or less participation in hobbies or social activities
  7. 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:

  1. Pregnant or lactating woman
  2. Oral contraceptives during last three months, including hormonal IUD (trade name mirena).
  3. Serious health problems.
  4. Unexplained menstrual disorders.
  5. Treated by hormones (estrogen and progesterone).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873262

Contacts
Contact: Yonit Bomstein, Dr. +972-54-7889917 ybomstein@evepms.com
Contact: Alek Itsekson, Dr. +972-50-5622098 itsekson@netvision.net.il

Locations
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.         
Sponsors and Collaborators
EVE Medical Systems Ltd.
Investigators
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:
Syndrome
Premenstrual Syndrome
Disease
Pathologic Processes
Menstruation Disturbances
Hormones
Estradiol
Polyestradiol phosphate
Progesterone
Estrone
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estrogens
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Progestins

ClinicalTrials.gov processed this record on October 01, 2014