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Completed

NCT Number: NCT00756561

HOP-2A - Intratesticular Hormone Levels

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

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Intratesticular Hormones in Normal Men

    Time frame: 6-weeks

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Intratesticular Hormone Levels in Healthy Young Men

Acronym: HOP-2A

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2008
Registry last updated
Jun 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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