Clinical trial NCT00756561: HOP-2A - Intratesticular Hormone Levels
Official title: Intratesticular Hormone Levels in Healthy Young Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Male Infertility
Prostate Disease
Keywords: Fine Needle Aspiration
Male Health
Male Contraception
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2008-09-22
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy males

Brief summary: The purpose of this investigational study is to find out what hormones are present in healthy male testicles using fine needle aspiration.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* males between 18 and 50 years of age
* sperm count greater than 20 million/ml, greater than 50% motility, and greater than 15% normal morphology
* in good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal sperm count, normal serum chemistry, hematology and baseline T, LH, and FSH levels)
* body mass index ≥18 and ≤32 kg/m2
* must agree not to participate in another research study involving drug exposure for the duration of the study

Exclusion Criteria:

* men in poor general health, with abnormal blood results
* sperm counts \<20 million/ml on two tests
* chronic, ongoing alcohol or drug abuse
* participation in a long-term male contraceptive study within the past three months
* history of testicular or scrotal surgery
* history of infertility
* abnormal testicular exam
* abnormal DRE
* chronic pain syndrome
* use of steroids, testosterone, or medications which might interfere with androgen metabolism including ketoconazole, glucocorticoids
* known bleeding disorder
* use of medications which may affect bleeding time (ongoing aspirin or anti-inflammatory use, coumadin)

Primary outcomes:
measure: Intratesticular Hormones in Normal Men
timeFrame: 6-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: John K Amory, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.