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Study stopped for procedural difficulties and lack of personnel
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The purpose of this trial is to evaluate the effect of testosterone replacement in men with renal failure (on dialysis) who also have low testosterone. Specifically, the investigators will assess the change in requirement of Erythropoietin Stimulating agents.
Testosterone replacement can increase hemoglobin count. This can therefore decrease the requirement of Erythropoietin Stimulating agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone | Active Comparator | Testosterone intramuscular every 2 weeks |
|
| Saline | Placebo Comparator | Saline intramuscular every 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | Testosterone |
| |
| Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dosage of Erythropoietin stimulating agents (ESA) | Comparison of dose of ESA in the 2 months prior to the start of the drug and in months 5 and 6. | primary outcome will be measured at months 5 and 6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandeep Dhindsa, MD | TTUHSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TTUHSC-Permian Basin | Odessa | Texas | 79763 | United States |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
Placebo |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |