Clomid To Raise Testosterone
Clomid in Men With Low Testosterone With and Without Prior Treatment
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| ClinicalTrials.gov Identifier: NCT01904734 |
| Recruitment Status : Completed First Posted : July 22, 2013 Last Update Posted : March 10, 2021 |
Sponsor:
Phoenix VA Health Care System
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 42 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| 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 |
| Actual Primary Completion Date : | October 31, 2018 |
| Actual Study Completion Date : | October 31, 2018 |
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:
|
| 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:
|
Primary Outcome Measures :
- Total serum testosterone [ Time Frame: at the end of 8 weeks of treatment ]
laboratory measurement by standard immunometric method
Secondary Outcome Measures :
- Bioavailable testosterone [ Time Frame: at the end of 8 weeks of treatment ]
Non-SHBG bound testosterone by ammonium sulfate precipitation method
- 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
Information from the National Library of Medicine
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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
| United States, Arizona | |
| Phoenix VA Health Care System | |
| Phoenix, Arizona, United States, 85012 | |
Sponsors and Collaborators
Phoenix VA Health Care System
Investigators
| Principal Investigator: | Sherman M Harman, MD, PhD | Phoenix VA Health Care System |
Publications:
| Responsible Party: | Sherman M. Harman, Chief, Endocrine Division, Dept. of Internal Medicine, Phoenix VA Health Care System |
| ClinicalTrials.gov Identifier: | NCT01904734 |
| Other Study ID Numbers: | VETSCLOMIDPHX |
| First Posted: | July 22, 2013 Key Record Dates |
| Last Update Posted: | March 10, 2021 |
| Last Verified: | March 2021 |
Keywords provided by Sherman M. Harman, Phoenix VA Health Care System:
| testosterone hypogonadism pituitary |
Additional relevant MeSH terms:
| Hypogonadism Eunuchism Gonadal Disorders Endocrine System Diseases Clomiphene Enclomiphene Zuclomiphene Estrogen Antagonists | Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Fertility Agents, Female Fertility Agents Reproductive Control Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators |
Source: https://clinicaltrials.gov/ct2/show/NCT01904734
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