HOP-2A - Intratesticular Hormone Levels

This study has been completed.
Information provided by (Responsible Party):
John Amory, University of Washington
ClinicalTrials.gov Identifier:
First received: September 18, 2008
Last updated: May 1, 2013
Last verified: May 2013

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

Male Infertility
Prostate Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Intratesticular Hormone Levels in Healthy Young Men

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Intratesticular Hormones in Normal Men [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
    Average between right and left testis for each subject and serum hormone concentration in 10 normal men

Biospecimen Retention:   Samples Without DNA

serum blood, testicular tissue

Enrollment: 10
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: January 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).


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


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

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Principal Investigator: John K Amory, MD, MPH University of Washington
  More Information

Additional Information:

Responsible Party: John Amory, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00756561     History of Changes
Other Study ID Numbers: 34593-B
Study First Received: September 18, 2008
Results First Received: November 8, 2010
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Fine Needle Aspiration
Male Health
Male Contraception

Additional relevant MeSH terms:
Infertility, Male
Prostatic Diseases
Genital Diseases, Male
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014