Clomid in Men With Low Testosterone With and Without Prior Treatment

Sponsor

Phoenix VA Health Care System (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT01904734

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism, Male	Drug: Clomiphene	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Comparison of Clomiphene Citrate Responses in Men With Hypothalamic Hypogonadism naïve to, and Previously Treated With, Testosterone

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Oct 31, 2018

Actual Study Completion Date :

Oct 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: No previous male hormone treatment Clomiphene	Drug: Clomiphene Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks Other Names: Clomid Clomiphene citrate
Active Comparator: Previously treated with testosterone Clomiphene	Drug: Clomiphene Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks Other Names: Clomid Clomiphene citrate

Arm

Intervention/Treatment

Active Comparator: No previous male hormone treatment

Clomiphene

Drug: Clomiphene

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

Other Names:

Clomid

Clomiphene citrate

Active Comparator: Previously treated with testosterone

Clomiphene

Drug: Clomiphene

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

Other Names:

Clomid

Clomiphene citrate

Outcome Measures

Primary Outcome Measures

Total serum testosterone [at the end of 8 weeks of treatment]
laboratory measurement by standard immunometric method

Secondary Outcome Measures

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