EUCTR2017-001012-11-GB进行中（未招募）1 期
A multicenter, open label, variable dose, two arm pilot paediatric phase 1 PK study to evaluate testosterone nasal gel (4.5% w/w) in hypogonadal boys
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •ARM 1 (naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
- •1. Hypogonadal boys
- •2. Chronological age 12 to <18 years;
- •3. No prior exposure to TRT;
- •4. Prepubertal;
- •5. Parent/guardian and patient able to understand and provide signed informed consent.
- •ARM 2 (non-naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
- •1. Hypogonadal boys with a bone age of =13 years; (a historical value within the last 12 months will be acceptable)
- •2. Chronological age 12 to <18 years;
- •3. Taking an existing TRT treatment dose;
- •4. Tanner Stage =3;
- •5. Parent/guardian and patient able to understand and provide signed informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •ARM 1 (naïve patients) AND ARM 2 (non-naïve patients): Participants who meet any of the following criteria will be excluded from participation in the study:
- •1. Any active allergic condition or presentation of symptoms including allergic rhinitis;
- •2. An upper respiratory tract infection;
- •3. Use of any form of intranasal medication delivery other than periodic short-term (less than 3 days) use of sympathomimetic decongestants, within the last 3 months;
- •4. In the opinion of the Investigator, significant intercurrent disease of any type, in particular liver, kidney, heart disease, stroke, or psychiatric illness;
- •5. Any active malignancy, however a prior history of a malignancy which has been in remission for 12 months will be allowed;
- •6. History of nasal disorders, nasal or sinus surgery, nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum surgery, mucosal inflammatory disorders, specifically Sjogren’s syndrome;
- •7. History of severe adverse drug reactions to testosterone therapies;
- •8. Current treatment with other androgens (e.g., dehydroepiandrosterone [DHEA]), anabolic steroids, or other sex hormones;
- •9. Treatment with drugs that interfere with the metabolism of testosterone, such as anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, or testolactone;
- •10. Diabetes mellitus;
- •11. Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study.
研究者
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