Clomid in Men With Low Testosterone With and Without Prior Treatment
Primary Purpose
Hypogonadism, Male
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Clomiphene
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism, Male focused on measuring testosterone, hypogonadism, pituitary
Eligibility Criteria
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)
Sites / Locations
- Phoenix VA Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
No previous male hormone treatment
Previously treated with testosterone
Arm Description
Clomiphene
Clomiphene
Outcomes
Primary Outcome Measures
Total serum testosterone
laboratory measurement by standard immunometric method
Secondary Outcome Measures
Bioavailable testosterone
Non-SHBG bound testosterone by ammonium sulfate precipitation method
Serum sex hormone binding globulin (SHBG)level
Laboratory measurement of SHBG by standard immunometric technique
Full Information
NCT ID
NCT01904734
First Posted
July 15, 2013
Last Updated
March 8, 2021
Sponsor
Phoenix VA Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT01904734
Brief Title
Clomid in Men With Low Testosterone With and Without Prior Treatment
Official Title
A Comparison of Clomiphene Citrate Responses in Men With Hypothalamic Hypogonadism naïve to, and Previously Treated With, Testosterone
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phoenix VA Health Care System
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Male
Keywords
testosterone, hypogonadism, pituitary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No previous male hormone treatment
Arm Type
Active Comparator
Arm Description
Clomiphene
Arm Title
Previously treated with testosterone
Arm Type
Active Comparator
Arm Description
Clomiphene
Intervention Type
Drug
Intervention Name(s)
Clomiphene
Other Intervention Name(s)
Clomid, Clomiphene citrate
Intervention Description
Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks
Primary Outcome Measure Information:
Title
Total serum testosterone
Description
laboratory measurement by standard immunometric method
Time Frame
at the end of 8 weeks of treatment
Secondary Outcome Measure Information:
Title
Bioavailable testosterone
Description
Non-SHBG bound testosterone by ammonium sulfate precipitation method
Time Frame
at the end of 8 weeks of treatment
Title
Serum sex hormone binding globulin (SHBG)level
Description
Laboratory measurement of SHBG by standard immunometric technique
Time Frame
at the end of 8 weeks of treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherman M Harman, MD, PhD
Organizational Affiliation
Phoenix VA Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix VA Health Care System
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22458540
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.
Results Reference
background
PubMed Identifier
22044663
Citation
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.
Results Reference
background
PubMed Identifier
19694928
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.
Results Reference
background
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Clomid in Men With Low Testosterone With and Without Prior Treatment
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