Clomid in Men With Low Testosterone With and Without Prior Treatment
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | October 2012 |
| End Date: | October 2015 |
A Comparison of Clomiphene Citrate Responses in Men With Hypothalamic Hypogonadism naïve to, and Previously Treated With, Testosterone
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.
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.
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.
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.
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)
We found this trial at
1
site
Phoenix, Arizona 85012
Principal Investigator: Sherman M Harman, MD, PhD
Phone: 602-277-5551
Click here to add this to my saved trials
