Clomid in Men With Low Testosterone With and Without Prior Treatment

March 8, 2021 updated by: Sherman M. Harman, Phoenix VA Health Care System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Phoenix VA Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total serum testosterone
Time Frame: at the end of 8 weeks of treatment
laboratory measurement by standard immunometric method
at the end of 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioavailable testosterone
Time Frame: at the end of 8 weeks of treatment
Non-SHBG bound testosterone by ammonium sulfate precipitation method
at the end of 8 weeks of treatment
Serum sex hormone binding globulin (SHBG)level
Time Frame: at the end of 8 weeks of treatment
Laboratory measurement of SHBG by standard immunometric technique
at the end of 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phoenix VA Health Care System

Investigators

  • Principal Investigator: Sherman M Harman, MD, PhD, Phoenix VA Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimate)

July 22, 2013

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VETSCLOMIDPHX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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