Hypogonadism, Male
Conditions
Keywords
testosterone, hypogonadism, pituitary
Brief summary
This study aims to explore whether men with low testosterone levels, due to altered brain regulation of male hormone function, who have been previously treated with testosterone, respond as well as men who have not been so treated to clomiphene citrate, an agent commonly used for female infertility that has been shown to improve male hormone secretion in some cases.
Detailed description
Clomiphene, an oral FDA-approved agent for female infertility has been shown to normalize testosterone levels in men with hypogonadotropic hypogonadism. It appears to be safe and well tolerated. This study will compare testosterone responses to clomiphene citrate in male veterans with hypothalamic hypogonadism naïve to treatment with responses of similar patients already receiving treatment with injectable or transdermal testosterone. This is an open-label, prospective, interventional trial to be conducted in an outpatient specialty care setting. We will randomize 64 hypogonadal male veterans evenly divided between naive and previous treatment and treat for 8 weeks with clomid, increasing the initial dose of 25 mg to 50 mg/day in those who fail to achieve target testosterone level (450 ng/dl) after the first 3 weeks. Endpoint measurements performed in the Phoenix VA Health Care System (PVAHCS) clinical laboratory will be total testosterone as well as bioavailable testosterone and sex hormone binding globulin. Total testosterone level at 8 weeks of treatment will be reported as the primary endpoint. Safety measures (CBC,liver functions, PSA) will be assessed at 8 weeks as well. This study will help serve as a guide for design of future studies of clomiphene in hypogonadal men.
Interventions
DRUGClomiphene
Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks
Sponsors
Phoenix VA Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient or eligible for care at Phoenix VA Health Care System * Male ages 30-70 years * testosterone level below 250 ng/dl before treatment * able to provide informed written consent
Exclusion criteria
* evidence of pituitary tumor \>1mm by MRI or CAT scan * chronic illness (renal, cardiac, liver failure) * Prostate specific antigen (PSA) \>4.0 ng/ml * history of prostate, breast, or testicular cancer * eye disease compromising vision (e.g. cataracts)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total serum testosterone | at the end of 8 weeks of treatment | laboratory measurement by standard immunometric method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bioavailable testosterone | at the end of 8 weeks of treatment | Non-SHBG bound testosterone by ammonium sulfate precipitation method |
| Serum sex hormone binding globulin (SHBG)level | at the end of 8 weeks of treatment | Laboratory measurement of SHBG by standard immunometric technique |
Countries
United States
Outcome results
None listed