NCT01175759

Role of Hypersensitivity to Female Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss

Evaluation of the Efficacy and Safety of the EVE- Skin-Test Panel in Detecting Sensitivity to Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: EVE Medical Systems Ltd. · Industry
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The EVE- technology is intended for determination of intolerance or sensitivity to female sex hormones among women with hormone-related conditions and for further treatment by desensitization procedure inducing a tolerance to the hormones the women are sensitive to. This study is designed to evaluate the safety and the ability of the EVE- Skin-Test Panel to detect sensitivity to female sex hormones in subjects with Unexplained Recurrent Pregnancy Loss (URPL) and in Control parous, healthy women. The Skin Test Panel includes four female hormones and three control solutions. Hormones from the Skin Test Panel are injected intradermally during the luteal phase of the subject's menstrual cycle. The skin reactions are examined by physician for erythema and wheal after 20 minutes and 48 hours and self-assessed by the patient daily for the following month. Skin response monthly data is analyzed and compared between unexplained recurrent pregnancy loss (UPRL) and healthy groups. Following achievement of the significant differences between both groups the immune profile of the healthy and UPRL subjects will be investigated.

Conditions

• Abortion, Recurrent

Interventions

Type	Name	Description
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: 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)
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: 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)

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-06-01
• Completion: 2011-12-01
• First posted: 2010-08-05
• Last updated: 2010-08-05

Locations

1 site across 1 country: Hungary