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| Name | Class |
|---|---|
| Clarus Therapeutics, Inc. | INDUSTRY |
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This study in being conducted in men who have low testosterone and chronic kidney disease. The investigators will evaluate the effects of an oral testosterone preparation, JATENZO, on testosterone levels and hemoglobin (red blood cells).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | JATENZO daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jatenzo Pill | Drug | oral tablet daily |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Testosterone concentrations | Testosterone concentrations in serum measured multiple times during the study | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | blood test | 6 months |
| muscle strength | Hand-grip strength will be measured by a quantitative handgrip dynamometer in the dominant arm. Mean of three consecutive measurements will be used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandeep Dhindsa, MD | Contact | 314-977-9320 | sandeep.dhindsa@health.slu.edu | |
| Jennifer Newman, RN | Contact | jennifer.newman@heath.slu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sandeep Dhindsa, MD | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis Univeristy | Recruiting | St Louis | Missouri | 63104 | United States |
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| ID | Term |
|---|---|
| D005058 | Eunuchism |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
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| ID | Term |
|---|---|
| D043343 | Testosterone Propionate |
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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All subjects will receive treatment with JATENZO
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| 6 months |
| Lean mass | measured by DEXA scan | 6 months |
| sexual function | Psychosexual daily questionnaire for 7 consecutive days will be used. The questionnaire covers three different domains: 1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual desire (question 1) and sexual enjoyment (question 2) will be rated on a 7-point Likert-type scale from 0 to 7, with 0 indicating none and 7 indicating very high. Sexual performance will be assessed by % full erection and satisfaction with erection (questions 5 and 6). Sexual activity (question 4) will be assessed using a checklist format. The value will be recorded as 0 (none) or 1 (any) for analysis. Higher score indicates higher activity; maximum score on this item is 12. Each mood parameter (question 3) will also be assessed on the 7-point Likert scale. | 6 months |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |