Premenstrual SyndromePhase 2NCT00873262
Evaluation of Safety/Efficacy of Diagnostic Skin Test Panel and Desensitization Hormone Kit for Treatment of Premenstrual Syndrome (PMS)
A Phase 2 study testing Skin test panel and desensitization kit and Skin test panel and solvent in people with Premenstrual Syndrome, run by EVE Medical Systems Ltd. at 1 site in Israel.
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) and desensitizes them with the relevant sex hormones in order to reduce PMS symptoms. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Skin test panel and desensitization kit and Skin test panel and solvent
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2009to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Shmuel Kivity, Prof., +972-3-697-3734, allergy@tasmc.health.gov.il
Tzipi Yemini, +972-3-697-3734, zipiy@tasmc.health.gov.il
About this study
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
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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Skin test panel and desensitization kit, Skin test panel and solvent
- Keywords
- PreMenstrual Syndrome, Hormones, Skin tests, Desensitization, Allergen Immunotherapy
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin test panel and desensitization kitDrug
Also called Progesterone, Estradiol, Estrone, Estriol
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
Skin test panel and solventDrug
Also called Progesterone, Estradiol, Estrone, Estriol
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
| Study group | Role | What they receive |
|---|---|---|
| Hormones | Active comparator | Not described Receives: Drug: Skin test panel and desensitization kit |
| Solvent | Placebo comparator | Not described Receives: Drug: Skin test panel and solvent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5-6 months
Secondary outcomes (1)
To assess the efficacy of hormonal desensitization compared to solvent treatment in reduction of the breast swelling and tenderness in 4 weeks of treatment.
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EVE Medical Systems Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shmuel Kivity, Prof., Principal investigator, Tel Aviv Sourasky Medical Center, Department of Allergy and clinical immunologyJacob Cohen, Dr., Principal investigator, Tel Aviv Sourasky Medical Center, Department of Outpatient Gynecology Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873262
- Sponsor's protocol ID
- EVE-2008-03
- Status last verified
- Feb 2010
- First submitted
- 30 Mar 2009
- Last updated
- 16 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00873262
- Acronym / sponsor ID
- EVE-2008-03
- Conditions
- Premenstrual Syndrome
- Keywords
- PreMenstrual Syndrome, Hormones, Skin tests, Desensitization, Allergen Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- EVE Medical Systems Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 1 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hormones | Active comparator | Drug: Skin test panel and desensitization kit |
| Solvent | Placebo comparator | Drug: Skin test panel and solvent |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin test panel and desensitization kitAlso: Progesterone, Estradiol, Estrone, EstriolSkin 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 | Drug | Hormones |
| Skin test panel and solventAlso: Progesterone, Estradiol, Estrone, EstriolSkin 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 | Drug | Solvent |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shmuel Kivity, Prof. principal investigator
Tel Aviv Sourasky Medical Center, Department of Allergy and clinical immunology
Jacob Cohen, Dr. principal investigator
Tel Aviv Sourasky Medical Center, Department of Outpatient Gynecology Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Skin test panel and desensitization kit and Skin test panel and solvent in people with Premenstrual Syndrome, run by EVE Medical Systems Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonit Bomstein, Dr. (+972-54-7889917, ybomstein@evepms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2010.