Clomid in Men With Low Testosterone With and Without Prior Treatment

Hypogonadism, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904734
• Other study ID #: VETSCLOMIDPHX
• Status: Completed
• Phase: Phase 2
• Start date: October 2012
• Est. completion date: October 31, 2018

Study information

• Verified date: March 2021
• Source: Phoenix VA Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadism, Male

Intervention

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

Locations

Country	Name	City	State
United States	Phoenix VA Health Care System	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix VA Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total serum testosterone	laboratory measurement by standard immunometric method	at the end of 8 weeks of treatment
Secondary	Bioavailable testosterone	Non-SHBG bound testosterone by ammonium sulfate precipitation method	at the end of 8 weeks of treatment
Secondary	Serum sex hormone binding globulin (SHBG)level	Laboratory measurement of SHBG by standard immunometric technique	at the end of 8 weeks of treatment