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| ID | Type | Description | Link |
|---|---|---|---|
| U54HD042454 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The original purpose of this research study was to understand the effects of testosterone (T) and estrogen on stem cells in the blood. The knowledge would be used to help understand the effects of T and estrogen on cardiovascular (heart and blood vessel) disease, and to help in the development of a safe male hormonal contraceptive.
The effect of androgens on the number of circulating endothelial progenitor (CEP) cells would best be observed in group 1 (placebo). Upon observation of group 1 under original protocol, changes in CEP cells were not significant but there were changes in markers of inflammation, lipids, and HDL protein composition. A modification to the protocol and title were made to reflect this for groups 2 and 3: Hormonal regulation of HDL-C in Men.
We will be administering three drugs: testosterone gel (T), anastrozole, and acyline. We want to see their effects on stem cells and hormone levels in the blood. Acyline suppress luteinizing hormone(LH) and follicle-stimulating hormone(FSH), which are hormones made by the pituitary gland, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore acyline blocks testosterone production. Some men may experience side effects such as hot flashes or irritability from the low levels of T caused by acyline. We are studying whether adding T to acyline will reduce or eliminate these side effects.
Since heart disease is a common problem in men we want to know about the effects of male hormonal contraception on the cardiovascular system. One way to evaluate these risks is to measure the number of progenitor cells and the types of cholesterol in the blood. Progenitor cells are cells that travel in the blood and go to areas of blood vessel injury to help repair the damage amd may help prevent heart attacks and stokes. Some studies suggest that T administration may increase the number of these cells in the blood but other studies have shown that estrogen may be responsible for this effect. In addition, T and estrogen may affect the amount and type of HDL cholesterol in the blood. This is the "good" cholesterol that is thought to protect people from heart attacks and strokes. Therefore, more studies to test the effects of T and estrogen on progenitor cells in the blood and to understand HDL cholesterol in men receiving testosterone are needed.
Acyline is an experimental drug. The FDA allows its use only in research with a small number of volunteers. So far, over 125 men have received acyline. Anastrozole is a drug that blocks the production of estrogen from testosterone. Anastrozole has been given to men safely in the past. Anastrozole is not approved for use in men and is also an experimental drug. Testosterone gel will also be used in this study. It is FDA approved for use in men with low testosterone levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Acyline 300 µg/kg injections every two weeks (2 doses) + placebo (no active ingredients) gel daily for 28 days + oral placebo pill daily for 28 days |
|
| Group 2 | Experimental | Acyline 300 µg/kg injections every two weeks (2 doses) + Testosterone gel 100 mg daily for 28 days + oral placebo pill daily for 28 days |
|
| Group 3 | Experimental | Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + oral anastrozole pill 1 mg daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acyline | Drug | Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + placebo Testosterone gel daily for 28 days + placebo oral anastrozole pill daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Progenitor Cells | Number of CD33 + CD134+ cells as a percentage of all lymphocytes | Baseline, Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Follicle Stimulating Hormone (FSH) | Baseline, 28 days | |
| Luteinizing Hormone Concentration (LH) | Baseline, Day 28 | |
| Testosterone Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Page, MD, PhD | University of Washington | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15687329 | Background | Phillips GB. Is atherosclerotic cardiovascular disease an endocrinological disorder? The estrogen-androgen paradox. J Clin Endocrinol Metab. 2005 May;90(5):2708-11. doi: 10.1210/jc.2004-2011. Epub 2005 Feb 1. | |
| 8636300 | Background | Bebb RA, Anawalt BD, Christensen RB, Paulsen CA, Bremner WJ, Matsumoto AM. Combined administration of levonorgestrel and testosterone induces more rapid and effective suppression of spermatogenesis than testosterone alone: a promising male contraceptive approach. J Clin Endocrinol Metab. 1996 Feb;81(2):757-62. doi: 10.1210/jcem.81.2.8636300. |
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Before study procedures,2 withdrew consent and 1 was withdrawn by the investigator for missing appointments.4 failed inclusion criteria(1-anemia,1-low testosterone,1-high BMI,1-medications.
31 men enrolled. 22 men completed.
Subjects were recruited using rosters from prior research studies, newspaper and online advertisements. Recruitment began December 2008 and ended March 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Acyline + Placebo Gel, Placebo Pill | Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days |
| FG001 | Group 2: Acyline, Testosterone Gel, Placebo Pill | Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days |
| FG002 | Group 3: Acyline, Testosterone Gel, Anastrazole Pill | Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Acyline + Placebo Gel, Placebo Pill | Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days |
| BG001 | Group 2: Acyline, Testosterone Gel, Placebo Pill |
| 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 | Endothelial Progenitor Cells | Number of CD33 + CD134+ cells as a percentage of all lymphocytes | Statistical analyses were limited to changes from baseline within a given group and between-group comparisons were not performed | Posted | Mean | Standard Deviation | percentage of all lymphocytes | Baseline, Day 28 |
|
Dec 2008 - May 2010
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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 | Group 1: Acyline + Placebo Gel, Placebo Pill | Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| emotional lability, irritability | Endocrine disorders | Systematic Assessment | This is expected in group 1 subjects (hypogonadal). The group 3 subject with emotional lability also reported skin irritation at the testosterone gel site. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie T. Page, MD, PhD | University of Washington | 206-616-0483 | page@u.washington.edu |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C109238 | acyline |
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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|
| Acyline + Testosterone gel | Drug | Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + placebo oral pill 1 mg daily for 28 days |
|
|
| Acyline + testosterone gel + anastrozole | Drug | Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + oral anastrozole pill 1 mg daily for 28 days |
|
|
| Baseline, Day 28 |
| Estradiol Concentration | Baseline, Day 28 |
| Sex Hormone Binding Globulin (SHBG) | Baseline, Day 28 |
| Quantitative Insulin Sensitivity Check Index (QUICKI) | QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity. | Baseline, Day 28, Day 56 |
| Homeostasis Model of Insulin Resistance (HOMA-IR) | HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity. | Baseline, Day 28, Day 56 |
| Fasting Serum Insulin | Baseline, Day 28, Day 56 |
| Fasting Lipid Levels | Baseline, Day 28, Day 56 |
| 12700179 | Background | Wu FC, von Eckardstein A. Androgens and coronary artery disease. Endocr Rev. 2003 Apr;24(2):183-217. doi: 10.1210/er.2001-0025. |
| 16983113 | Background | Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006 Sep 20;24(27):4448-56. doi: 10.1200/JCO.2006.06.2497. |
| 15072892 | Background | Smith MR. Changes in fat and lean body mass during androgen-deprivation therapy for prostate cancer. Urology. 2004 Apr;63(4):742-5. doi: 10.1016/j.urology.2003.10.063. |
| 11836291 | Background | Smith MR, Finkelstein JS, McGovern FJ, Zietman AL, Fallon MA, Schoenfeld DA, Kantoff PW. Changes in body composition during androgen deprivation therapy for prostate cancer. J Clin Endocrinol Metab. 2002 Feb;87(2):599-603. doi: 10.1210/jcem.87.2.8299. |
| 16434464 | Background | Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. doi: 10.1210/jc.2005-2507. Epub 2006 Jan 24. |
| 16921050 | Background | Braga-Basaria M, Dobs AS, Muller DC, Carducci MA, John M, Egan J, Basaria S. Metabolic syndrome in men with prostate cancer undergoing long-term androgen-deprivation therapy. J Clin Oncol. 2006 Aug 20;24(24):3979-83. doi: 10.1200/JCO.2006.05.9741. |
| 16148285 | Background | Werner N, Kosiol S, Schiegl T, Ahlers P, Walenta K, Link A, Bohm M, Nickenig G. Circulating endothelial progenitor cells and cardiovascular outcomes. N Engl J Med. 2005 Sep 8;353(10):999-1007. doi: 10.1056/NEJMoa043814. |
| 12829619 | Background | Werner N, Junk S, Laufs U, Link A, Walenta K, Bohm M, Nickenig G. Intravenous transfusion of endothelial progenitor cells reduces neointima formation after vascular injury. Circ Res. 2003 Jul 25;93(2):e17-24. doi: 10.1161/01.RES.0000083812.30141.74. Epub 2003 Jun 26. |
| 11440984 | Background | Vasa M, Fichtlscherer S, Aicher A, Adler K, Urbich C, Martin H, Zeiher AM, Dimmeler S. Number and migratory activity of circulating endothelial progenitor cells inversely correlate with risk factors for coronary artery disease. Circ Res. 2001 Jul 6;89(1):E1-7. doi: 10.1161/hh1301.093953. |
| 17391216 | Background | Dong C, Goldschmidt-Clermont PJ. Endothelial progenitor cells: a promising therapeutic alternative for cardiovascular disease. J Interv Cardiol. 2007 Apr;20(2):93-9. doi: 10.1111/j.1540-8183.2007.00251.x. |
| 16926245 | Background | Foresta C, Caretta N, Lana A, De Toni L, Biagioli A, Ferlin A, Garolla A. Reduced number of circulating endothelial progenitor cells in hypogonadal men. J Clin Endocrinol Metab. 2006 Nov;91(11):4599-602. doi: 10.1210/jc.2006-0763. Epub 2006 Aug 22. |
| 17573901 | Background | Foresta C, Zuccarello D, Biagioli A, De Toni L, Prana E, Nicoletti V, Ambrosini G, Ferlin A. Oestrogen stimulates endothelial progenitor cells via oestrogen receptor-alpha. Clin Endocrinol (Oxf). 2007 Oct;67(4):520-5. doi: 10.1111/j.1365-2265.2007.02918.x. Epub 2007 Jun 15. |
| 17803706 | Background | Foresta C, Zuccarello D, De Toni L, Garolla A, Caretta N, Ferlin A. Androgens stimulate endothelial progenitor cells through an androgen receptor-mediated pathway. Clin Endocrinol (Oxf). 2008 Feb;68(2):284-9. doi: 10.1111/j.1365-2265.2007.03036.x. Epub 2007 Sep 4. |
| 14676142 | Background | Iwakura A, Luedemann C, Shastry S, Hanley A, Kearney M, Aikawa R, Isner JM, Asahara T, Losordo DW. Estrogen-mediated, endothelial nitric oxide synthase-dependent mobilization of bone marrow-derived endothelial progenitor cells contributes to reendothelialization after arterial injury. Circulation. 2003 Dec 23;108(25):3115-21. doi: 10.1161/01.CIR.0000106906.56972.83. Epub 2003 Dec 15. |
| 15326314 | Background | Bergt C, Pennathur S, Fu X, Byun J, O'Brien K, McDonald TO, Singh P, Anantharamaiah GM, Chait A, Brunzell J, Geary RL, Oram JF, Heinecke JW. The myeloperoxidase product hypochlorous acid oxidizes HDL in the human artery wall and impairs ABCA1-dependent cholesterol transport. Proc Natl Acad Sci U S A. 2004 Aug 31;101(35):13032-7. doi: 10.1073/pnas.0405292101. Epub 2004 Aug 23. |
| 12519853 | Background | Leder BZ, LeBlanc KM, Schoenfeld DA, Eastell R, Finkelstein JS. Differential effects of androgens and estrogens on bone turnover in normal men. J Clin Endocrinol Metab. 2003 Jan;88(1):204-10. doi: 10.1210/jc.2002-021036. |
| 17510436 | Background | Mostaghel EA, Page ST, Lin DW, Fazli L, Coleman IM, True LD, Knudsen B, Hess DL, Nelson CC, Matsumoto AM, Bremner WJ, Gleave ME, Nelson PS. Intraprostatic androgens and androgen-regulated gene expression persist after testosterone suppression: therapeutic implications for castration-resistant prostate cancer. Cancer Res. 2007 May 15;67(10):5033-41. doi: 10.1158/0008-5472.CAN-06-3332. |
| 16882745 | Background | Page ST, Lin DW, Mostaghel EA, Hess DL, True LD, Amory JK, Nelson PS, Matsumoto AM, Bremner WJ. Persistent intraprostatic androgen concentrations after medical castration in healthy men. J Clin Endocrinol Metab. 2006 Oct;91(10):3850-6. doi: 10.1210/jc.2006-0968. Epub 2006 Aug 1. |
| 16352669 | Background | Page ST, Plymate SR, Bremner WJ, Matsumoto AM, Hess DL, Lin DW, Amory JK, Nelson PS, Wu JD. Effect of medical castration on CD4+ CD25+ T cells, CD8+ T cell IFN-gamma expression, and NK cells: a physiological role for testosterone and/or its metabolites. Am J Physiol Endocrinol Metab. 2006 May;290(5):E856-63. doi: 10.1152/ajpendo.00484.2005. Epub 2005 Dec 13. |
| 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. |
| 14671195 | Background | Mauras N, Lima J, Patel D, Rini A, di Salle E, Kwok A, Lippe B. Pharmacokinetics and dose finding of a potent aromatase inhibitor, aromasin (exemestane), in young males. J Clin Endocrinol Metab. 2003 Dec;88(12):5951-6. doi: 10.1210/jc.2003-031279. |
| 17594720 | Background | Lin EH, Hassan M, Li Y, Zhao H, Nooka A, Sorenson E, Xie K, Champlin R, Wu X, Li D. Elevated circulating endothelial progenitor marker CD133 messenger RNA levels predict colon cancer recurrence. Cancer. 2007 Aug 1;110(3):534-42. doi: 10.1002/cncr.22774. |
| 12584367 | Background | Hill JM, Zalos G, Halcox JP, Schenke WH, Waclawiw MA, Quyyumi AA, Finkel T. Circulating endothelial progenitor cells, vascular function, and cardiovascular risk. N Engl J Med. 2003 Feb 13;348(7):593-600. doi: 10.1056/NEJMoa022287. |
| 12161475 | Background | Gonzalo IT, Swerdloff RS, Nelson AL, Clevenger B, Garcia R, Berman N, Wang C. Levonorgestrel implants (Norplant II) for male contraception clinical trials: combination with transdermal and injectable testosterone. J Clin Endocrinol Metab. 2002 Aug;87(8):3562-72. doi: 10.1210/jcem.87.8.8710. |
| 21797916 | Result | Rubinow KB, Snyder CN, Amory JK, Hoofnagle AN, Page ST. Acute testosterone deprivation reduces insulin sensitivity in men. Clin Endocrinol (Oxf). 2012 Feb;76(2):281-8. doi: 10.1111/j.1365-2265.2011.04189.x. |
| 22266332 | Result | Rubinow KB, Tang C, Hoofnagle AN, Snyder CN, Amory JK, Heinecke JW, Page ST. Acute sex steroid withdrawal increases cholesterol efflux capacity and HDL-associated clusterin in men. Steroids. 2012 Apr;77(5):454-60. doi: 10.1016/j.steroids.2012.01.002. Epub 2012 Jan 15. |
Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days |
| BG002 | Group 3: Acyline, Testosterone Gel, Anastrazole Pill | Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| OG002 | Group 3: Acyline + T-gel + Oral Anastrozole 1mg | Acyline SQ inj. Day 0 & 14 + T-gel and anastrozole for 28 days |
|
|
|
| Secondary | Follicle Stimulating Hormone (FSH) | Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3. | Posted | Mean | Standard Deviation | IU/L | Baseline, 28 days |
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| Secondary | Luteinizing Hormone Concentration (LH) | The analysis was per protocol. Following screening, the first 8 subjects were assigned to group I, and subsequent subjects enrolled were randomly assigned to either group 2 or 3. | Posted | Mean | Standard Deviation | IU/L | Baseline, Day 28 |
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| Secondary | Testosterone Concentration | Per protocol, the first 8 subjects were assigned to group I. Subsequent subjects were randomized to group 2 or group 3. | Posted | Mean | Standard Deviation | nmol/L | Baseline, Day 28 |
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| Secondary | Estradiol Concentration | Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3. | Posted | Mean | Standard Deviation | pmol/L | Baseline, Day 28 |
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| Secondary | Sex Hormone Binding Globulin (SHBG) | Per protocol, the first 8 subjects were assigned to Group I. Subsequent subjects were randomly assigned to Group 2 or Group 3. | Posted | Mean | Standard Deviation | nmol/L | Baseline, Day 28 |
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| Secondary | Quantitative Insulin Sensitivity Check Index (QUICKI) | QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity. | per protocol | Posted | Mean | Standard Deviation | QUICKI index | Baseline, Day 28, Day 56 |
|
|
|
| Secondary | Homeostasis Model of Insulin Resistance (HOMA-IR) | HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity. | per protocol | Posted | Mean | Standard Deviation | HOMA score | Baseline, Day 28, Day 56 |
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| Secondary | Fasting Serum Insulin | per protocol | Posted | Mean | Standard Deviation | picomolar | Baseline, Day 28, Day 56 |
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| Secondary | Fasting Lipid Levels | per protocol | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 28, Day 56 |
|
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|
| 0 |
| 8 |
| 6 |
| 8 |
| EG001 | Group 2: Acyline, Testosterone Gel, Placebo Pill | Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days | 0 | 6 | 1 | 6 |
| EG002 | Group 3: Acyline, Testosterone Gel, Anastrazole Pill | Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days | 0 | 8 | 2 | 8 |
|
| fatigue | Endocrine disorders | Systematic Assessment | Fatigue is anticipated and consistent with hypogonadal symptoms for Group 1 (placebo gel. The group 2 subject also reported studying late and spending the night in the library during midterm week. Fatigue is described in the consent as a possibility. |
|
| hot flashes | Endocrine disorders | Systematic Assessment | Hot flashes are anticipated and consistent with hypogonadal symptoms for Group 1 (placebo gel). This is described in the consent. |
|
| itching at acyline site | Skin and subcutaneous tissue disorders | Systematic Assessment | The written consent describes itchiness at the site in most men. One (group 2)is not counted here, but is described in "participant flow". Symptoms had resolved on Day 14 but he withdrew consent before the second acyline injection. |
|
| lightheadedness, clammy | Endocrine disorders | Systematic Assessment | Mild symptoms occurred two days and were deemed possibly related to the drug. No action or medications were required in this group I (hypogonadal symptoms expected) subject. |
|
| low libido | Endocrine disorders | Systematic Assessment | Low libido is anticipated and consistent with hypogonadal symptoms for Group 1 (placebo gel). This is described in the consent. |
|
| skin irritation, gel application site | Skin and subcutaneous tissue disorders | Systematic Assessment | One(group 1) complaint of itchiness;one(group 3) complaint of dry skin at testosterone gel application site. Both subjects were instructed to apply elsewhere; complaints were resolved with no further symptoms at old and new application sites. |
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| itching rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Day 56 |
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| Day 56 |
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| Day 56 |
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| Total cholesterol Day 56 |
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| LDL choesterol Day 0 |
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| LDL cholesterol Day 28 |
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| LDL cholesterol Day 56 |
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| HDL cholesterol Day 0 |
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| HDL cholesterol Day 28 |
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| HDL cholesterol Day 56 |
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| Triglycerides Day 0 |
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| Triglycerides Day 28 |
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| Triglycerides Day 56 |
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