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Early Experience with Subcutaneous Injection of Non-Proprietary Testosterone as an Alternative Approach for Testosterone Replacement (2022)
KAlter, DRoadman, CAmarasekera, LLevine


Introduction

Testosterone replacement therapy (TRT) has been demonstrated to benefit men with a diagnosis of hypogonadism. We elected to offer a non-proprietary subcutaneous injection (subQ) using a ½ inch 27g needle for TRT as an alternative treatment for hypogonadism.


Objective

To investigate the effect of subQ TRT in hypogonadal men, in order to compare satisfaction, HCT, and PSA levels to other forms of TRT.

subcutaneous versus intramuscular IM testosterone injections.jpg

Methods

The study period was defined as the most recent follow-up appointment after beginning subQ TRT with a mean follow-up of 4.2 months (range 1-6 months). Variables were obtained prior to beginning subQ TRT and at the last follow-up visit. Patients either began subQ TRT primarily or switched from another method. Additionally, patients completed a satisfaction survey. Statistical analysis was performed with SPSS 24. Associations between testosterone levels and clinical variables were analyzed by univariate analysis.


Results

32 total patients received subQ TRT. Pre and post-subQ TRT testosterone levels (increased 299.7 +/- 61.5), HCT levels (increased 0.8 +/- 1.0%), PSA levels (increased 0.87 +/- 0.3 ng/mL), AUASS (decreased 3.7 +/- 1.7), and SHIM scores (increased 2.1 +/- 2.4) were recorded (Table 1). 21 patients received other forms of TRT prior to beginning subQ TRT and variables were collected and analyzed (Table 2). Overall, 21 patients completed the follow-up satisfaction survey. 19 (90.5%) were satisfied with subQ TRT and 2 (9.5%) patients attributed their dissatisfaction to greater symptom improvement on previous therapies (Testopel, Jatenzo). 11 (84.6%) patients reported better or same satisfaction on subQ TRT than with prior therapy. Furthermore, 8 (88.9%) patients said subQ TRT was easier to use than prior TRT injection (Intramuscular and Testopel), while 1 (11.1%) patient preferred fewer treatments with Testopel. Lastly, all patients reported subQ TRT as less painful during administration.


Conclusions

SubQ TRT led to higher testosterone levels, positive satisfaction scores, and improved AUASS and SHIM scores at the most recent follow-up. There was also no significant change to HCT or PSA levels. Ongoing monitoring focusing on longer duration of follow-up, erythrocytosis, satisfaction, and side effects are being conducted and will be reported.
 
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"19 (90.5%) were satisfied with subQ TRT and 2 (9.5%) patients attributed their dissatisfaction to greater symptom improvement on previous therapies (Testopel, Jatenzo). 11 (84.6%) patients reported better or same satisfaction on subQ TRT than with prior therapy. Furthermore, 8 (88.9%) patients said subQ TRT was easier to use than prior TRT injection (Intramuscular and Testopel), while 1 (11.1%) patient preferred fewer treatments with Testopel. Lastly, all patients reported subQ TRT as less painful during administration."
 
Our Experience with Subcutaneous Injection of Non-Proprietary Testosterone Cypionate as a Novel Approach for Hypogonadism (2023)
A Spellman, K Alter, L Levine


Abstract

Introduction


Subcutaneous injection of testosterone has been investigated as a method of testosterone replacement therapy (TRT) in hypogonadal men. We have been investigating the use of a non-proprietary subcutaneous (SubQ) injection of testosterone cypionate using a ½ inch 27g needle for the replacement to treat hypogonadism. This is an update on our work which includes larger sample size and longer follow-up.


Objective

To assess the use of non-proprietary SubQ TRT as treatment in hypogonadal men and its effect on HCT, PSA, and patient satisfaction.


Methods

This study is a retrospective chart review of patients receiving SubQ TRT with a mean follow-up length of 9.8 months (range 0-24 months). Patient data were collected prior to the initiation of therapy and at subsequent visits. Testosterone, HCT, and PSA were determined through regular blood draws and a patient satisfaction survey was performed over the phone. Univariate analysis and paired t-tests were used to analyze study variables.


Results

41 total patients received SubQ TRT. Mean changes in total testosterone level (increased 281.3 + 81.1, p-value=0.0008), hematocrit (increased 1.5 + 1.0), PSA (increased 0.4 + 0.4), SHIM score (increased 3.8 + 1.4, p-value=0.0088) and AUA symptom score (decreased 0.9 + 1.6) were calculated at the patients’ initial visit and most recent follow up while still on SubQ TRT (Table 1). A total of 30 patients had been on various combinations of TRT before switching to SubQ including IM (13), CC (13) Testopel (8), HCG (2) SubQ (2), T gel (1) and Anastrozole (1). Data on the most frequent TRTs are demonstrated in Table 2. Patient satisfaction surveys were completed by 32 patients (78%), with 26 (81.2%) patients reporting overall satisfaction with SubQ TRT versus 45% (9/20) with past forms of TRT. 93.7% (15/16) reported SubQ TRT was both easier and less painful, and 73.6% (14/19) preferred SubQ injections over their previous form of TRT. Reasons for stopping SubQ TRT included unrelated stroke (1), prostate cancer (1), development of scar tissue (1) or bruising (1), ineffective therapy (1), difficulty drawing up the syringe (1), cost (1), and trouble obtaining medication from the pharmacy (1).


Conclusions

The use of non-proprietary testosterone cypionate SubQ as a treatment for hypogonadism results in an elevation in serum total testosterone and improvement in both SHIM and AUA symptom scores at follow-up. PSA and HCT rose over the span of treatment, but the rises were not statistically significant, and no patient developed erythrocytosis. Our data demonstrate SubQ TRT is easier and less painful to use and scores higher on overall patient satisfaction compared to other forms of TRT.
 
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