Clomid in Men With Low Testosterone With and Without Prior Treatment

Phase 2

Completed

• Conditions: Hypogonadism, Male
• Interventions: Drug: Clomiphene

• Registration Number: NCT01904734
• Lead Sponsor: Phoenix VA Health Care System

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-22
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No previous male hormone treatment	Clomiphene	Clomiphene
Previously treated with testosterone	Clomiphene	Clomiphene

Primary Outcome Measures

Name	Time	Method
Total serum testosterone	at the end of 8 weeks of treatment	laboratory measurement by standard immunometric method

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Phoenix VA Health Care System; 🇺🇸 Phoenix, Arizona, United States