Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel

NCT00866437 | Unknown Phase 2 DMC

• 1 other identifier: EveMS-0908
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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). 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.

Conditions

Premenstrual Syndrome

Keywords

PMS; Hormones; Skin tests; Allergen Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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

  Total study duration will be approximately 2-3 months

Secondary Outcomes (1)

• Minimal skin test related adverse events.

  2-3 Months

Study Arms (2)

Healthy Control group

EXPERIMENTAL

Drug: Skin test panel

PMS

EXPERIMENTAL

Drug: Skin test panel

Interventions

Skin test panel DRUG

Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators. Hormones: 1. Progesterone 1mmol/L 2. Estradiol 1mmol/L 3. Estrone 3mmol/L 4. Estriol 3mmol/l Controls: 5. Saline (NaCl) 0.9% 6. Ethyl Oleate with 10% Benzyl Alcohol 7. Histamine phosphate 1mg/ml (epicutaneous- prick test)

Also known as: Progesterone, Estradiol, Estrone, Estriol

Healthy Control group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EVE Medical Systems Ltd.: lead

Study Sites (1)

Sheba Medical Center, Tel-Hashomer

Ramat Efal, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Progesterone; Estradiol; Estrone; Estriol

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Estrenes; Estranes; Estradiol Congeners; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones

Study Officials

• Avner Reshef, Dr.

  Allergy and clinical Immunology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonit Bomstein, Dr.

CONTACT

+972-54-7889917; ybomstein@evepms.com

Alek Itsekson, Dr.

CONTACT

+972-50-5622098; itsekson@netvision.net.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 16, 2010

Record last verified: 2010-02

Locations

IL (1)