Gonadotropin Deficiency
Conditions
Keywords
intratesticular androgens, testosterone, dutasteride, gonadotropin suppression, male contraception, spermatogenesis
Brief summary
The purpose of this investigational drug study is to determine how much male hormone, testosterone, is needed to maintain sperm production in the testis.
Detailed description
This is a nine-month research study examining the effects on androgen treatment on sperm production in healthy men. There are three phase to the study, a 2-month screening phase, 4-month treatment and 3-month follow-up. In this study, the investigators aim to define a quantitative relationship between intra-testicular testosterone (IT-T) and spermatogenesis in man. Hormone levels will be measured in a small amount of testicular fluid at the beginning and end of treatment and sperm concentration will be measured.
Interventions
DRUGTestosterone 1% Gel
Testosterone 1% gel 5g daily for 4 months \[all subjects\]
DRUGAcyline
Acyline 300 ug/kg SQ injections every 2-weeks for 4 months \[all subjects\]
DRUGDutasteride
Dutasteride 2.5 mg (day 1) followed by 0.5 mg daily for 4 months
DRUGKetoconazole
ketoconazole 400 mg PO daily for 4 months
DRUGHCG
HCG 60 IU injection Subcutaneously, every other day for 4 months
placebo oral dutasteride PO daily for 4 months
placebo ketoconazole daily for 4 months
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Males age 18-55 * In general good health based on normal screening evaluation * Normal serum testosterone, lutenizing hormone (LH) and follicle stimulating hormone (FSH) * Prostate Specific Antigen (PSA) \< 3.0 * Agrees not to donate blood or participate in another research study during the study * Informed consent * Must be willing to use a reliable form of contraception during the study
Exclusion criteria
* Participation in a long-term male contraceptive study within the past three months * History of testosterone or anabolic steroid abuse in the past * History of or current skin disorder that will interfere with testosterone gel * Poor general health or significantly abnormal screening blood results * History of or current testicular or prostate disease * History of a bleeding disorder or need for anticoagulation * History of untreated sleep apnea and/or major psychiatric problems * BMI \> 32 * History of or current liver disease * Chronic pain syndrome * Current use of terfenidine, astemizole, cisapride, budesonide, felodipine, fluticasone, lovastatin, midazolam, sildenafil, or vardenafil * Use of glucocorticoids or underlying adrenal insufficiency * Active drug or alcohol abuse within the past year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sperm concentration | 16 weeks | Difference in sperm concentration at week 16 between 4 treatment groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IT steroid concentration | 16 weeks | It steroid concentration at week 16 between the 4 treatment groups |
Countries
United States
Outcome results
None listed