Clinical trial NCT01904734: Clomid in Men With Low Testosterone With and Without Prior Treatment
Official title: A Comparison of Clomiphene Citrate Responses in Men With Hypothalamic Hypogonadism naïve to, and Previously Treated With, Testosterone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism, Male
Keywords: testosterone
hypogonadism
pituitary
Lead sponsor: Phoenix VA Health Care System
Sponsor class: FED
First posted: 2013-07-22
Enrollment: 42
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total serum testosterone
timeFrame: at the end of 8 weeks of treatment
Secondary outcomes:
measure: Bioavailable testosterone
timeFrame: at the end of 8 weeks of treatment
measure: Serum sex hormone binding globulin (SHBG)level
timeFrame: at the end of 8 weeks of treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Health Care System
state: Arizona
Study officials:
affiliation: Phoenix VA Health Care System
name: Sherman M Harman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moskovic DJ, Katz DJ, Akhavan A, Park K, Mulhall JP. Clomiphene citrate is safe and effective for long-term management of hypogonadism. BJU Int. 2012 Nov;110(10):1524-8. doi: 10.1111/j.1464-410X.2012.10968.x. Epub 2012 Mar 28.
citation: Katz DJ, Nabulsi O, Tal R, Mulhall JP. Outcomes of clomiphene citrate treatment in young hypogonadal men. BJU Int. 2012 Aug;110(4):573-8. doi: 10.1111/j.1464-410X.2011.10702.x. Epub 2011 Nov 1.
citation: Taylor F, Levine L. Clomiphene citrate and testosterone gel replacement therapy for male hypogonadism: efficacy and treatment cost. J Sex Med. 2010 Jan;7(1 Pt 1):269-76. doi: 10.1111/j.1743-6109.2009.01454.x. Epub 2009 Aug 17.