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| ID | Type | Description | Link |
|---|---|---|---|
| U54HD42456-06 | Other Grant/Funding Number | NIH/NICHD | |
| K23HD045386 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.
This is an 2-3 month open-label, two week pharmacokinetic study of two novel formulations of oral testosterone (T), in normal men whose endogenous T production has been temporarily suppressed by the administration of the potent GnRH antagonist Acyline. We will be determining the relative pharmacokinetics of six different oral formulations of T in both rapid and slow release compared to the immediate release preparation studied previously by our group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral testosterone | Experimental | (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. |
|
| Finasteride plus Oral Testosterone | Experimental | (Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acyline | Drug | 300 mcg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve-Serum T | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve-serum DHT | 14-days | |
| Area Under the Curve-E2 | 14 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John K Amory | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Plymate SR "Male Hypogonadism" in Principles and Practice of Endocrinology and Metabolism (3rd. Ed). Ed. Kenneth Becker, pp:1125-1150 | ||
| 15713724 | Background | Amory JK, Bremner WJ. Oral testosterone in oil plus dutasteride in men: a pharmacokinetic study. J Clin Endocrinol Metab. 2005 May;90(5):2610-7. doi: 10.1210/jc.2004-1221. Epub 2005 Feb 15. | |
| 16400081 |
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19 participants recruited; 19 screened, 2 excluded.
Subjects were recruited through news media (newspaper, website) and college campus bulletin boards in Seattle WA, between April 2008-March 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone Only | (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. |
| FG001 | Testosterone Plus Finasteride | (Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone Only | (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve-Serum T | Posted | Mean | Standard Error | nmol*h/L | 14 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Testosterone Only | (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased Libido | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John K Amory, MD, MPH | University of Washington | 206-616-1727 | jamory@u.washington.edu |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C109238 | acyline |
| D013739 | Testosterone |
| D018120 | Finasteride |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Testosterone |
| Drug |
24 hours after acyline administration on Day 2 "immediate release" Testosterone (T) 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. |
|
|
| Finasteride | Drug | 1 mg PO once daily [day -2 to day 12) 14 days total](streamdown:incomplete-link) |
|
|
| Background |
| Amory JK, Page ST, Bremner WJ. Oral testosterone in oil: pharmacokinetic effects of 5alpha reduction by finasteride or dutasteride and food intake in men. J Androl. 2006 Jan-Feb;27(1):72-8. doi: 10.2164/jandrol.05058. |
| 15579744 | Background | Herbst KL, Coviello AD, Page S, Amory JK, Anawalt BD, Bremner WJ. A single dose of the potent gonadotropin-releasing hormone antagonist acyline suppresses gonadotropins and testosterone for 2 weeks in healthy young men. J Clin Endocrinol Metab. 2004 Dec;89(12):5959-65. doi: 10.1210/jc.2003-032123. |
| 20378927 | Result | Snyder CN, Clark RV, Caricofe RB, Bush MA, Roth MY, Page ST, Bremner WJ, Amory JK. Pharmacokinetics of 2 novel formulations of modified-release oral testosterone alone and with finasteride in normal men with experimental hypogonadism. J Androl. 2010 Nov-Dec;31(6):527-35. doi: 10.2164/jandrol.109.009746. Epub 2010 Apr 8. |
| BG001 | Testosterone Plus Finasteride | (Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Estradiol | Mean | Standard Deviation | pmol/L |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Sex Hormone Binding Globulin (SHBG) | Mean | Standard Deviation | nmol/L |
|
| Testosterone (T) | Mean | Standard Deviation | nmol/L |
|
| Weight | Mean | Standard Deviation | kilogram |
|
|
|
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| Secondary | Area Under the Curve-serum DHT | Posted | Mean | Standard Error | nmol*h/L | 14-days |
|
|
|
|
| Secondary | Area Under the Curve-E2 | Posted | Mean | Standard Deviation | nmol*h/L | 14 Days |
|
|
|
|
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | Testosterone Plus Finasteride | (Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. | 0 | 8 | 6 | 8 |
| Elevated aspartate aminotransferase | Endocrine disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Hot flashes | Endocrine disorders | Systematic Assessment |
|
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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 |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| external matrix 'slow' release |
|
| external matrix 'slow' release |
|