HOP-2A - Intratesticular Hormone Levels

Completed

• Conditions: Healthy; Male Infertility; Prostate Disease

• Registration Number: NCT00756561
• Lead Sponsor: University of Washington

Brief Summary

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

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).

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Primary Completion: 2009-01
• Study Completion: 2009-12
• Results First Submitted: 2010-11-08
• Results First Submitted QC: 2013-05-01
• Results First Posted: 2013-07-19
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intratesticular Hormones in Normal Men	6-weeks	Average between right and left testis for each subject and serum hormone concentration in 10 normal men

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States