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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001766-42 | EudraCT Number | ||
| IRAS project ID: 146877 | Other Identifier | NHS London - West London & GTAC Research Ethics Committee |
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| Name | Class |
|---|---|
| Advanced Therapies Centre, The London Clinic | OTHER |
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This study is a continuation of previous studies done in healthy volunteers to prove the efficacy of delivering Testosterone, the male hormone, rapidly across intact skin in s series of doses from low to high in men with low-to-no natural testosterone production to measure their response to the varying doses. The results of this study will inform further studies which will be longer in length, as to the starting doses. The study will be conducted in London, U.K. at the Advanced Therapies Centre, The London Clinic.
48 Patients will be enrolled following 2 independent verifying blood tests of their diagnosis of Hypogonadism. there will be 4 cohorts of 12 subjects, each receiving doses of the trail materials, titrated by means of number of sprays applied. Doses will range from 10 to 70 mgs Testosterone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Forearm dose | Active Comparator | Half of Ss will receive their dose of Testosterone on the inner aspects of their forearms. |
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| Chest Dose | Active Comparator | Half of Ss will receive their dose of Testosterone on the chest. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | 10,30,50 and 70 mg doses of micronized Testosterone delivered by means of a new liquid transdermal delivery solution, HypoSpray(R)once daily for 7 days or until halted due to systemic or dermal reactions. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Range Measure of serum levels of testosterone in response to varying doses | A pharmacokinetic measure of serum levels of testosterone in response to varying doses of from 10 to 70 mgs of Testosterone. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Dermal Safety as measured by | Incidence of treatment-emergent side effects. | 1 Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shern L. Chew, M.D., Ph.D. | Contact | 011-44-20 034 6227 | sl.chew@thelondonclinic.co.uk | |
| Chandan AS Alam, MD | Contact | 011-44-7785-717596 | calam@tdsc.us |
| Name | Affiliation | Role |
|---|---|---|
| Shern L. Chew, M.D., Ph.D. | Consultant Physician and Professor of Endocrine Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Therapies Centre, The London Clinic | London | NW1 4LJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16487220 | Background | Chik Z, Johnston A, Tucker AT, Chew SL, Michaels L, Alam CA. Pharmacokinetics of a new testosterone transdermal delivery system, TDS-testosterone in healthy males. Br J Clin Pharmacol. 2006 Mar;61(3):275-9. doi: 10.1111/j.1365-2125.2005.02542.x. |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Pump Sprayer | Device | A dose of product solution is delivered by means of a metered pump spray. |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |