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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001767-23 | EudraCT Number | ||
| IRAS project ID: 146877 | Other Identifier | 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 will assess the potential of Testagen® TDS-Testosterone to enable transfer of Testosterone to females coming in contact with skin to which Testagen® TDS-Testosterone has been applied and the potential of product to raise serum androgen levels in those women.
48 Couples will be added to the protocol and a single dose applied by the male member of the couple. The female member of the couple will have undergone a baseline pharmacokinetic monitoring of her endogenous levels of Testosterone. At precise intervals by cohort on the day of the trial, the male will expose the skin onto which the trial materials were applied to the skin of his partner and she will then undergo another 24-hour multiple sample monitoring of her levels of testosterone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uncovered | Experimental | Half of the male partners in each cohort will apply the Testagen® TDS Testosterone 5% HypoSpray® and cover the area before engaging in contact with the female partner. |
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| Covered | Experimental | Half of the male partners in each cohort will apply the Testagen® TDS Testosterone 5% HypoSpray® and will not cover the area before engaging in contact with the female partner. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testagen® TDS Testosterone 5% HypoSpray® | Drug | Topically applied Testosterone Hormone Replacement Lotion |
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| Measure | Description | Time Frame |
|---|---|---|
| Transference of Topical Testosterone from Dosed Males to Female Partners As Measured by net change from Baseline of Serum Testosterone in nG/dL expressed as Maximum Serum Concentration or Cmax. | Determination of whether testosterone from the Testagen® preparation is transferable from the skin of the patient to his partner and therefore detectable in the blood of female partner and if so, how much as measured by ELISA method as applied to blood samples and computed for Concentration Max (Cmax) for 24 hours post dose measured in ng/dL Testosterone as determined by ELISA method. | 30 minutes to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Transference of Topical Testosterone from Dosed Males to Female Partners As Measured by net change from Baseline of Serum Testosterone in nG/dL expressed as Area Under Curve or AUC. | Determination of whether testosterone from the Testagen® preparation is transferable from the skin of the patient to his partner and therefore detectable in the blood of female partner and if so, how much as measured by ELISA method as applied to blood samples and computed for Area Under the Curve (AUC) for 24 hours post dose measured in ng/dL Testosterone as determined by ELISA method. |
| Measure | Description | Time Frame |
|---|---|---|
| Transference of Topical Testosterone from Dosed Males with application area covered to Female Partners As Measured by net change from Baseline of Serum Testosterone in nG/dL expressed as Maximum Serum Concentration or Cmax | Determination of whether testosterone from the Testagen® preparation is transferable from the skin of the patient with application area covered to his partner and therefore detectable in the blood of female partner and if so, how much as measured by ELISA method as applied to blood samples and computed for Concentration Max (Cmax) and Area Under the Curve (AUC) for 24 hours post dose measured in ng/dL Testosterone as determined by ELISA method. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chandan A.S. Alam, M.D. | Contact | 02082456222 | Chandan1@aol.com |
| Name | Affiliation | Role |
|---|---|---|
| Chandan A.S. Alam, M.D. | Consultant Physician | Principal Investigator |
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| Label | URL |
|---|---|
| Chik Z, Johnston A, Tucker AT, Chew SL, Michaels L, Alam CA. Pharmacokinetics of a new testosterone transdermal delivery system, TDStestosterone in healthy males. Br J Clin Pharmacol. 2006 Mar;61(3):2759. | View source |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| 30 minutes to 24 hours post dose |
| 30 minutes to 24 hours post dose |
| Transference of Topical Testosterone from Dosed Males with application area covered to Female Partners As Measured by net change from Baseline of Serum Testosterone in nG/dL expressed as Area Under the Curve or AUC | Determination of whether testosterone from the Testagen® preparation is transferable from the skin of the patient and therefore detectable in the blood of the female partner with application area covered to his partner and if so, how much as measured by ELISA method as applied to blood samples and computed Area Under the Curve (AUC) for 24 hours post dose measured in ng/dL Testosterone as determined by ELISA method. | 30 minutes to 24 hours post dose |