| Trial ID: | L0547 |
| Source ID: | NCT05249634
|
| Associated Drug: |
Jatenzo Pill
|
| Title: |
Testosterone Treatment in Men with Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypogonadism, Male|Kidney Disease, Chronic
|
| Interventions: |
DRUG: Jatenzo Pill
|
| Outcome Measures: |
Primary: Testosterone concentrations, Testosterone concentrations in serum measured multiple times during the study, 6 months | Secondary: 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., 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
|
| Sponsor/Collaborators: |
Sponsor: St. Louis University | Collaborators: Clarus Therapeutics, Inc.
|
| Gender: |
MALE
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-03-15
|
| Completion Date: |
2028-12
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-30
|
| Locations: |
Saint Louis Univeristy, Saint Louis, Missouri, 63104, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05249634
|
