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Clomid in Men With Low Testosterone With and Without Prior Treatment

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ClinicalTrials.gov Identifier: NCT01904734
Recruitment Status : Unknown
Verified October 2015 by Sherman M. Harman, Phoenix VA Health Care System.
Recruitment status was:  Recruiting
First Posted : July 22, 2013
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Sherman M. Harman, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 : October 2012
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Total serum testosterone [ Time Frame: at the end of 8 weeks of treatment ]
    laboratory measurement by standard immunometric method


Secondary Outcome Measures :
  1. Bioavailable testosterone [ Time Frame: at the end of 8 weeks of treatment ]
    Non-SHBG bound testosterone by ammonium sulfate precipitation method

  2. 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



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904734


Locations
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United States, Arizona
Phoenix VA Health Care System Recruiting
Phoenix, Arizona, United States, 85012
Contact: John Matchette, PA    602-277-5551 ext 6114    john.matchette@va.gov   
Contact: Sherman M Harman, MD, PhD    602-277-5551 ext 7095    sherman.harman@va.gov   
Principal Investigator: Sherman M Harman, MD, PhD         
Sponsors and Collaborators
Phoenix VA Health Care System
Investigators
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Principal Investigator: Sherman M Harman, MD, PhD Phoenix VA Health Care System

Publications:
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Responsible Party: Sherman M. Harman, Chief, Endocrine Division, Dept. of Internal Medicine, Phoenix VA Health Care System
ClinicalTrials.gov Identifier: NCT01904734     History of Changes
Other Study ID Numbers: VETSCLOMIDPHX
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by Sherman M. Harman, Phoenix VA Health Care System:
testosterone
hypogonadism
pituitary

Additional relevant MeSH terms:
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Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Methyltestosterone
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Estrogen Antagonists
Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents