Clomid in Men With Low Testosterone With and Without Prior Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypogonadism, Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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No previous male hormone treatment

Clomiphene

Group Type ACTIVE_COMPARATOR

Clomiphene

Intervention Type DRUG

Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks

Previously treated with testosterone

Clomiphene

Group Type ACTIVE_COMPARATOR

Clomiphene

Intervention Type DRUG

Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks

Interventions

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Clomiphene

Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks

Intervention Type DRUG

Other Intervention Names

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Clomid Clomiphene citrate

Eligibility Criteria

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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)

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No