HOP-2A - Intratesticular Hormone Levels (HOP-2A)

May 10, 2016 updated by: John Amory, University of Washington

Intratesticular Hormone Levels in Healthy Young Men

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Healthy males

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 19, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Estimate)

June 13, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34593-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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