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

Premenstrual Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00866437
• Other study ID #: EveMS-0908
• Status: Recruiting
• Phase: Phase 2
• First received: March 19, 2009
• Last updated: June 15, 2010
• Start date: April 2009
• Est. completion date: November 2010

Study information

• Verified date: February 2010
• Source: EVE Medical Systems Ltd.
• Contact: Yonit Bomstein, Dr.
• Phone: +972-54-7889917
• Email: ybomstein[@]evepms.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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:

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:

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).

6. For healthy: Irregular or abnormal test results.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Premenstrual Syndrome

Intervention

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: 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)
• Skin test panel
Hormones: Progesterone 1mmol/L Estradiol 1 mmol/L Estrone 3 mmol/L Estriol 3mmol/l Controls: Saline (NaCl) 0.9% Ethyl Oleate with 10% Benzyl Alcohol Histamine phosphate 1mg/ml (epicutaneous- prick test)

Locations

Country	Name	City	State
Israel	Sheba Medical Center, Tel-Hashomer	Ramat Efal

Sponsors (1)

Lead Sponsor	Collaborator
EVE Medical Systems Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Minimal skin test related adverse events.		2-3 Months	Yes