N/A
N=10
HOP-2A - Intratesticular Hormone Levels
Healthy · Male Infertility · Prostate Disease
Bottom Line
View on ClinicalTrials.gov: NCT00756561 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Intratesticular Hormones in Normal Men — 486; 3.0; 3.7; 0.20 ng/mL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Washington
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intratesticular Hormones in Normal Men |
486; 3.0; 3.7; 0.20; 2.7; 0.025 | — |
Summary
The purpose of this investigational study is to find out what hormones are present in healthy male testicles using fine needle aspiration.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00756561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.