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Status unknownNCT00866437Updated Jun 16, 2010

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

A Phase 2 interventional study of Skin test panel and Skin test panel in Premenstrual Syndrome, sponsored by EVE Medical Systems Ltd.. Status unknown at 1 site in Israel. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-06-16.

Sponsored by EVE Medical Systems Ltd. · Phase 2, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Premenstrual Syndrome

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Keywords

  • PMS
  • Hormones
  • Skin tests
  • Allergen Immunotherapy
03

In context

Premenstrual Syndrome

182 studies on the registry are indexed under Premenstrual Syndrome; 30 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 157 interventional studies indexed under Premenstrual Syndrome.

Browse Premenstrual Syndrome studies →

Lead sponsor

EVE Medical Systems Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Care provider)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Healthy Control group

    Drug: Skin test panel

  • Experimental
    PMS

    Drug: Skin test panel

Interventions

  • DrugSkin test panel

    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

  • DrugSkin test panel

    Hormones: 1. Progesterone 1mmol/L 2. Estradiol 1 mmol/L 3. Estrone 3 mmol/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

06

What researchers measure

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

    Time frame: Total study duration will be approximately 2-3 months

Secondary outcomes

  1. Minimal skin test related adverse events.

    Time frame: 2-3 Months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2009, a primary completion of May 2010 and a completion of Nov 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2009
First posted
Mar 20, 2009
Start
Apr 2009
Primary completionEst.
May 2010
CompletionEst.
Nov 2010
Last update
Jun 16, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00866437
Lead sponsor
EVE Medical Systems Ltd.
First posted
Mar 20, 2009
Start date
Apr 2009
Primary completion
May 2010 (estimated)
Completion
Nov 2010 (estimated)
Last update
Jun 16, 2010

Study contacts

Yonit Bomstein, Dr.
Contact
ybomstein@evepms.com
+972-54-7889917
Alek Itsekson, Dr.
Contact
itsekson@netvision.net.il
+972-50-5622098
Avner Reshef, Dr.
principal investigator · Allergy and clinical Immunology Department

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Progesterone

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EVE Medical Systems Ltd.

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