HOP-2A - Intratesticular Hormone Levels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Amory, University of Washington
ClinicalTrials.gov Identifier:
NCT00756561
First received: September 18, 2008
Last updated: May 1, 2013
Last verified: May 2013
  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

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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Publications:

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

ClinicalTrials.gov processed this record on September 16, 2014