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The purpose of this investigational study is to find out what hormones are present in healthy male testicles using fine needle aspiration.
We will collect a very small amount of fluid from each testicle. Participation will last up to 12 weeks. The study involves a minimum of 4 visits, the screening visit and procedure Day, fine needle aspiration of the testes (about 1-1.5 hours each) and two follow-up visits (about 30-45 minutes). Over the course of the study, you will have a little less than a 1/3-cup of blood drawn (roughly 2-3 tablespoons at each visit).
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| Measure | Description | Time Frame |
|---|---|---|
| Intratesticular Hormones in Normal Men | Average between right and left testis for each subject and serum hormone concentration in 10 normal men | 6-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy males
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| Name | Affiliation | Role |
|---|---|---|
| John K Amory, MD, MPH | 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 |
|---|---|---|---|
| 16940442 | Background | Page ST, Amory JK, Anawalt BD, Irwig MS, Brockenbrough AT, Matsumoto AM, Bremner WJ. Testosterone gel combined with depomedroxyprogesterone acetate is an effective male hormonal contraceptive regimen and is not enhanced by the addition of a GnRH antagonist. J Clin Endocrinol Metab. 2006 Nov;91(11):4374-80. doi: 10.1210/jc.2006-1411. Epub 2006 Aug 29. | |
| 15867009 |
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15 screened, 3 did not meet inclusion criteria (2 for abnormal semen parameters, 1 for abnormal liver function), 1 decided not to enroll, and 1 did not complete study procedures because of study end. Data analysis was performed on the first 10 of 11 subjects completing procedures.
Subjects were recruited through news media (newspaper, website) and college campus bulletin boards in Seattle, WA, between September - December 2008. All visits were at the University of Washington, Seattle, WA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Normal Males | Men, 18-50 years of age, in good health |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Normal Males | Men, 18-50 years of age, in good health |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Intratesticular Hormones in Normal Men | Average between right and left testis for each subject and serum hormone concentration in 10 normal men | per protocol | Posted | Median | Inter-Quartile Range | ng/mL | 6-weeks |
|
4 months
The first subject was screened 9/26/2008; the last subject exited 1/16/2009. Subjects in the study are asked about adverse events and concomitant medications at every visit.
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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 | Healthy Normal Males | Men, 18-50 years of age, in good health |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| discomfort at lidocaine injection site | Reproductive system and breast disorders | Systematic Assessment | reported discomfort from 11/5/08 to 12/2/08. Discomfort usually ends within a few days; this subject habitually bicycled 20 miles per day, and was advised to reduce bicycling for a short time. |
Early termination of study leading to data analysis of the first ten of eleven men receiving aspirations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mara Roth, MD | University of Washington, Dept. of Medicine | (206) 221-0519 | mylang@u.washington.edu |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D011469 | Prostatic Diseases |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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serum blood, testicular tissue
| Anawalt BD, Amory JK, Herbst KL, Coviello AD, Page ST, Bremner WJ, Matsumoto AM. Intramuscular testosterone enanthate plus very low dosage oral levonorgestrel suppresses spermatogenesis without causing weight gain in normal young men: a randomized clinical trial. J Androl. 2005 May-Jun;26(3):405-13. doi: 10.2164/jandrol.04135. |
| 15477366 | Background | Coviello AD, Bremner WJ, Matsumoto AM, Herbst KL, Amory JK, Anawalt BD, Yan X, Brown TR, Wright WW, Zirkin BR, Jarow JP. Intratesticular testosterone concentrations comparable with serum levels are not sufficient to maintain normal sperm production in men receiving a hormonal contraceptive regimen. J Androl. 2004 Nov-Dec;25(6):931-8. doi: 10.1002/j.1939-4640.2004.tb03164.x. |
| 15713727 | Background | Coviello AD, Matsumoto AM, Bremner WJ, Herbst KL, Amory JK, Anawalt BD, Sutton PR, Wright WW, Brown TR, Yan X, Zirkin BR, Jarow JP. Low-dose human chorionic gonadotropin maintains intratesticular testosterone in normal men with testosterone-induced gonadotropin suppression. J Clin Endocrinol Metab. 2005 May;90(5):2595-602. doi: 10.1210/jc.2004-0802. Epub 2005 Feb 15. |
| 17494097 | Background | Page ST, Kalhorn TF, Bremner WJ, Anawalt BD, Matsumoto AM, Amory JK. Intratesticular androgens and spermatogenesis during severe gonadotropin suppression induced by male hormonal contraceptive treatment. J Androl. 2007 Sep-Oct;28(5):734-41. doi: 10.2164/jandrol.107.002790. Epub 2007 May 9. |
| 15579324 | Background | Zhao M, Baker SD, Yan X, Zhao Y, Wright WW, Zirkin BR, Jarow JP. Simultaneous determination of steroid composition of human testicular fluid using liquid chromatography tandem mass spectrometry. Steroids. 2004 Oct-Nov;69(11-12):721-6. doi: 10.1016/j.steroids.2004.05.020. |
| 17764104 | Background | Kalhorn TF, Page ST, Howald WN, Mostaghel EA, Nelson PS. Analysis of testosterone and dihydrotestosterone from biological fluids as the oxime derivatives using high-performance liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom. 2007;21(19):3200-6. doi: 10.1002/rcm.3205. |
| 19779211 | Result | Roth MY, Lin K, Amory JK, Matsumoto AM, Anawalt BD, Snyder CN, Kalhorn TF, Bremner WJ, Page ST. Serum LH correlates highly with intratesticular steroid levels in normal men. J Androl. 2010 Mar-Apr;31(2):138-45. doi: 10.2164/jandrol.109.008391. Epub 2009 Sep 24. |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Body Mass Index (BMI) | Median | Inter-Quartile Range | kg/m^2 |
|
| Sperm concentration | Median | Inter-Quartile Range | millions/mL |
|
| Luteinizing Hormone (LH) | Median | Inter-Quartile Range | IU/L |
|
| Follicle Stimulating Hormone (FSH) | Median | Inter-Quartile Range | IU/L |
|
| Serum Testosterone (T) | Median | Inter-Quartile Range | ng/mL |
|
| Serum Dihydrotestosterone (DHT) | Median | Inter-Quartile Range | ng/mL |
|
| Serum Estradiol (E2) | Median | Inter-Quartile Range | ng/mL |
|
| Testis volume | volume for left and right testis | Median | Inter-Quartile Range | mL |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 11 |
| 4 |
| 11 |
|
| bruised ribs | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subject is security officer and bruised ribs while restraining someone. |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Subjects did not take any medications for their colds. |
|
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| D052801 |
| Male Urogenital Diseases |