NCT00873262

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

Status unknown Phase 2 Last updated 15 June 2010

What this trial tests

Phase 2 trial testing Skin test panel and desensitization kit in Premenstrual Syndrome in 20 participants. Status unknown.

Timeline

1 April 2009

Primary endpoint
1 May 2010

1 November 2010

Quick facts

Lead sponsor	EVE Medical Systems Ltd.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	1 April 2009
Primary completion	1 May 2010
Estimated completion	1 November 2010
Sites	1 location across Israel

Drugs / interventions tested

• Skin test panel and desensitization kit — full drug profile →
• Skin test panel and solvent — full drug profile →

Conditions studied

• Premenstrual Syndrome — all drugs for Premenstrual Syndrome →

Sponsor

EVE Medical Systems Ltd. — full company profile →

Who can join

Adults 20 to 45, female only, with Premenstrual Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and value of skin test to sex hormones and sex hormone sensitivity desensitization in women with premenstrual syndrome.
   Itsekson AM, Yonit B, Ze'ev IH, Matitiyahu Z, et al · · 2019 · cited 2× · PMID 31198489 · DOI 10.1016/j.waojou.2019.100041