HOP-2A - Intratesticular Hormone Levels

NCT00756561 | Completed Results

• 1 other identifier: 34593-B
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Male Infertility; Prostate Disease

Keywords

Fine Needle Aspiration; Male Health; Male Contraception

Outcome Measures

Primary Outcomes (1)

• Intratesticular Hormones in Normal Men

  Average between right and left testis for each subject and serum hormone concentration in 10 normal men

  6-weeks

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy males

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (8)

• 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.

  PMID: 16940442 BACKGROUND

• 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.

  PMID: 15867009 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.

  PMID: 15477366 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.

  PMID: 15713727 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.

  PMID: 17494097 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.

  PMID: 15579324 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.

  PMID: 17764104 BACKGROUND

• 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.

  PMID: 19779211 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum blood, testicular tissue

MeSH Terms

Conditions

Infertility, Male; Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Limitations and Caveats

Early termination of study leading to data analysis of the first ten of eleven men receiving aspirations.

Results Point of Contact

• Title: Mara Roth, MD
• Organization: University of Washington, Dept. of Medicine

mylang@u.washington.edu

(206) 221-0519

Study Officials

• John K Amory, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 22, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 13, 2016
• Results First Posted: July 19, 2013

Record last verified: 2016-05

Locations

US (1)