Clomid in Men With Low Testosterone With and Without Prior Treatment
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01904734 |
Recruitment Status :
Completed
First Posted : July 22, 2013
Last Update Posted : March 10, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypogonadism, Male | Drug: Clomiphene | Phase 2 |
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 |

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:
|
- Total serum testosterone [ Time Frame: at the end of 8 weeks of treatment ]laboratory measurement by standard immunometric method
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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)

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
United States, Arizona | |
Phoenix VA Health Care System | |
Phoenix, Arizona, United States, 85012 |
Principal Investigator: | Sherman M Harman, MD, PhD | Phoenix VA Health Care System |
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 |
testosterone hypogonadism pituitary |
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 |