HOP-2A - Intratesticular Hormone Levels

Healthy Clinical Trial

— HOP-2A  

Official title:

Intratesticular Hormone Levels in Healthy Young Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756561
• Other study ID #: 34593-B
• Status: Completed
• Phase: N/A
• First received: September 18, 2008
• Last updated: May 1, 2013
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Healthy
• Infertility, Male
• Male Infertility
• Prostate Disease
• Prostatic Diseases

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. Epub 2005 Feb 15. — View 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. — View 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. Epub 2006 Aug 29. — View 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. Epub 2007 May 9. — View 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 S — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intratesticular Hormones in Normal Men	Average between right and left testis for each subject and serum hormone concentration in 10 normal men	6-weeks	No

External Links

•   Dedicated to basic and clinical research focused primarily on the male reproductive system.