HOP-2A - Intratesticular Hormone Levels - Full Text View

Sponsored by:	University of Washington
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00756561

Purpose

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

Condition
Healthy Male Infertility Prostate Disease

Genetics Home Reference related topics: Y chromosome infertility

MedlinePlus related topics: Infertility Prostate Diseases

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Intratesticular Hormone Levels in Healthy Young Men

Further study details as provided by University of Washington:

Primary Outcome Measures:

To define a normal range of intra-testicular testosterone, dihydrotestosterone, and estradiol levels in healthy young men. [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare results for intra-testicular testosterone, dihydrotestosterone and estradiol levels using our liquid chromatography tandem mass spectrometry with those reported by other groups. [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

serum blood, testicular tissue

Estimated Enrollment:	10
Study Start Date:	September 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy males

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756561

Contacts

Contact: Iris Nielsen	206-221-5473	nielseni@u.washington.edu
Contact: Kathy Winter	206-616-0484	malectr@u.washington.edu

Locations

United States, Washington
University of Washington	Recruiting
Seattle, Washington, United States, 98195
Contact: Iris Nielsen 206-221-5473 nielseni@u.washington.edu
Contact: Kathy Winter 206-616-0484 klwinter@u.washington.edu
Sub-Investigator: Christin Snyder, MD
Sub-Investigator: Stephanie T Page, MD, PhD
Sub-Investigator: Mara Roth, MD
Sub-Investigator: Bradley Anawalt, MD
Sub-Investigator: Alvin M Matsumoto, MD
Sub-Investigator: Richard Berger, MD
Sub-Investigator: Thomas F Kalhorn
Sub-Investigator: Katherine Lin, MD
Sub-Investigator: William J Bremner, MD, PhD

Sponsors and Collaborators

University of Washington

Investigators

Principal Investigator:

John K Amory, MD, MPH

University of Washington

More Information

Additional Information:

Dedicated to basic and clinical research focused primarily on the male reproductive system. This link exits the ClinicalTrials.gov site

Publications:

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 Aug 29; [Epub ahead of print]

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.

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.

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.

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.

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.

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.

Responsible Party:	University of Washington ( William J Bremner, MD, PhD )
Study ID Numbers:	34593-B
Study First Received:	September 18, 2008
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00756561 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

Fine Needle Aspiration
Male Health
Male Contraception

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Prostatic Diseases
Infertility, Male

Healthy
Genital Diseases, Male
Hormones

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Prostatic Diseases
Infertility, Male
Genital Diseases, Male

ClinicalTrials.gov processed this record on May 07, 2009