Sub-q Testosterone Autoinjector is a safe and effective alternative method for TRT

madman

Super Moderator
Introduction: Xyosted® is a subcutaneous testosterone enanthate-autoinjector (SCTE-AI) which was approved by the Food and Drug Administration in 2018 for patient-administered weekly testosterone replacement therapy (TRT).

Objective: This is the largest non-industry sponsored post-market study to evaluate the safety and efficacy profile of SCTE-AI in outpatient urology clinics.

Methods: From January to October 2019, 110 hypogonadal men were treated with SCTE-AI at a two-institutions. Patients were assessed in a pre-therapy visit prior to receiving SCTE-AI and re-assessed at 6-weeks after treatment initiation. Patients with a history of prostate cancer were excluded. Trough serum total testosterone (TT), estradiol, prostate-specific antigen (PSA), and hematocrit (HCT) levels were collected at clinic visits. Therapeutic phlebotomy was recommended for HCT>54%, and treatment was discontinued for significant increases in PSA and for significant treatment-related adverse events. Values from each visit were compared with univariate analysis.

Results: 110 patients completed the 6 weeks of observation with a mean age of 40.3 ± 10.5. TT significantly rose from 246.6 ± 113.3 ng/dL pretherapy to 538.4 ± 209.3 ng/dL at 6 weeks, p<0.001. Post-therapy, 101/110 (91.8%) of patients had TT>300 ng/dL (Table). No patients had HCT > 54%. 74 patients (70.5%) had PSA increase with only 3 (2.9%) experiencing an increase >1.0. There was a significant increase in mean PSA from 1.07 ± 0.8 pretherapy to 1.18 ± 0.9 at 6 weeks, p= 0.01. One patient had immediate treatment cessation following the discovery of prostate cancer.

Conclusions: This is the largest non-industry sponsored safety and efficacy profile of SCTE-AI application in urology clinics. After 6 weeks of observation, TT levels increased significantly. SCTE-AI is a safe and effective alternative method for TRT.



Table: Total Testosterone (TT) ranges before and after 6 weeks of SCTE-AI therapy














Pre-Therapy

6 weeks





TT (ng/dL)

n

%

n

%

0-300

96

87.3%

9

8.2%

300-1000

14

12.7%

97

88.2%

>1000

0

0.0%

4

3.6%
 
Post-Market Safety and Efficacy Profile of Subcutaneous Testosterone Enanthate-Autoinjector (2020)



Choi, E; Xu, P; Loeb, C; El-Khatib, F; Yafi, F; Kavoussi, P
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The myth needs to be put to rest that injecting T sub-q is inferior to IM when it comes to absorption/effectiveness for F**K S**E!
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*This is the largest non-industry sponsored post-market study to evaluate the safety and efficacy profile of SCTE-AI in outpatient urology clinics
 

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