Clomid in Men With Low Testosterone With and Without Prior Treatment

Phoenix VA Health Care System

Status and phase: Completed; Phase 2

Conditions: Hypogonadism, Male

Treatments: Drug: Clomiphene

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01904734

VETSCLOMIDPHX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Male

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

No previous male hormone treatment

Active Comparator group

Description:

Clomiphene

Treatment:

Drug: Clomiphene

Previously treated with testosterone

Active Comparator group

Description:

Clomiphene

Treatment:

Drug: Clomiphene