Testosterone Cypionate Injection (Depo-Testosterone)

Number: 1014

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Note: Most policies specifically exclude coverage of steroids for performance enhancement. For plans without this exclusion, androgens and anabolic steroids as well as other medical interventions for performance enhancement are not covered because performance enhancement of non-diseased individuals is not considered treatment of disease or injury. Please check benefit plan descriptions for details.

1. Prescriber Specialties

   For gender dysphoria, the medication must be prescribed by or in consultation with a provider specialized in the care of transgender youth (e.g., pediatric endocrinologist, family or internal medicine physician, obstetrician-gynecologist) that has collaborated care with a mental health provider for members less than 18 years of age.

2. Criteria for Initial Approval

   Aetna consider testosterone cypionate injection (Depo-Testosterone or generic formulation) medically necessary for the following indications:

   1. Primary hypogonadism or hypogonadotropic hypogonadism when both of the following criteria are met:

      1. Before the start of testosterone therapy, the member has at least two confirmed low morning testosterone levels according to current practice guidelines or your standard lab reference values; and
      2. The requested drug is not being prescribed for age-related hypogonadism; or
         

   2. Gender dysphoria

      1. When all of the following are met:

         1. The member has a diagnosis of gender dysphoria; and
         2. The member is able to make an informed decision to engage in hormone therapy; and
         3. The member's comorbid conditions are reasonably controlled; and
         4. The member has been educated on any contraindications and side effects to therapy; and
         5. The member has been informed of fertility preservation options; or
            

      2. In an adolescent member when all of the following criteria are met:

         1. The member has a diagnosis of gender dysphoria; and
         2. The member is able to make an informed decision to engage in hormone therapy; and
         3. The member has reached Tanner stage 2 of puberty or greater; and
         4. The member’s comorbid conditions are reasonably controlled; and
         5. The member has been educated on any contraindications and side effects to therapy; and
         6. The member has been informed of fertility preservation options.

   Aetna considers all other indications as experimental and investigational (for additional information, see Experimental and Investigational and Background sections).

3. Continuation of Therapy

   Aetna considers continuation of testosterone cypionate injection (Depo-Testosterone or generic formulation) therapy medically necessary for the following indications:

   1. Primary hypogonadism or hypogonadotropic hypogonadism when all of the following criteria are met:

      1. Before the member started testosterone therapy, the member had a confirmed low morning testosterone level according to current practice guidelines or per standard lab reference values; and
      2. The requested drug is not being prescribed for age-related hypogonadism; or

   2. Gender dysphoria

      1. When all of the following are met:

         1. The member has a diagnosis of gender dysphoria; and
         2. The member is able to make an informed decision to engage in hormone therapy; and
         3. The member's comorbid conditions are reasonably controlled; and
         4. The member has been educated on any contraindications and side effects to therapy; and
         5. Before the start of therapy, the member has been informed of fertility preservation options; or
            

      2. In adolescent members when all of the following criteria are met:

         1. The member has a diagnosis of gender dysphoria; and
         2. The member is able to make an informed decision to engage in hormone therapy; and
         3. The member has previously reached Tanner stage 2 of puberty or greater; and
         4. The member’s comorbid conditions are reasonably controlled; and
         5. The member has been educated on any contraindications and side effects to therapy; and
         6. Before the start of therapy, the member has been informed of fertility preservation options.

4. Related Policies

   For oral / buccal, topical or nasal androgen and anabolic steroid products, refer to pharmacy benefit plan.

   See also:

   1. CPB 0345 - Implantable Hormone Pellets
   2. CPB 0501 - Gonadotropin-Releasing Hormone Analogs and Antagonists
   3. CPB 0528 - Testosterone Undecanoate Injection (Aveed)
   4. CPB 0574 - Female Sexual Dysfunction (FSD)
   5. CPB 1015 - Testosterone Enanthate Injection.

Dosage and Administration

Depo-Testosterone injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate, for deep gluteal intramuscular (IM) injection only. Testosterone cypionate is also available in generic formulation in 200 mg/mL in a single-dose vial, which is administered by a healthcare provider.

Primary or hypogonadotropic hypogonadism

Prior to initiating testosterone cypionate, diagnosis of hypogonadism should be confirmed by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

The suggested dosage for Depo-Testosterone Injection varies depending on the age, sex, and diagnosis of the individual. Dosage is adjusted according to the person's response and the appearance of adverse reactions.

Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.

For replacement in the hypogonadal male, the recommended dose is 50mg to 400 mg administered every two to four weeks.

Source: Pharmacia and Upjohn, 2018; Slayback Pharma, 2022

Experimental and Investigational 

Aetna considers testosterone cypionate injections experimental and investigational for the following indications (not an all-inclusive list) because of insufficient evidence in the peer-reviewed literature:

• Age-related hypogonadism or late-onset hypogonadism
• Female sexual dysfunction / hypoactive sexual desire disorder
• Heart failure
• Hormonal replacement in prostate cancer survivors with testosterone deficiency
• Improvement of cognitive function in aging men
• Menopause (female or male).

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Other CPT codes related to the CPB:
84402	Testosterone; free
84403	total
84410	bioavailable, direct measurement (eg, differential precipitation)
96372	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular
99506	Home visit for intramuscular injection
HCPCS codes covered if selection criteria are met:
J1071	Injection, testosterone cypionate, 1 mg
ICD-10 codes covered if selection criteria are met:
E23.0	Hypopituitarism [Hypogonadotropic hypogonadism]
E29.1	Testicular hypofunction [not covered for age-related hypogonadism]
F64.0 – F64.9	Gender identity disorders
ICD-10 codes not covered for indications listed in the CPB (not all inclusive):
F52.0	Hypoactive sexual desire disorder
F52.22	Female sexual arousal disorder
I50.1 – I50.9	Heart failure
N95.1	Menopausal and female climacteric states
R41.81	Age-related cognitive decline [improvement of cognitive function in aging men]
Z78.0	Asymptomatic menopausal state
Z85.46	Personal history of malignant neoplasm of prostate

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Background

U.S. Food and Drug Administration (FDA)-Approved Indications 

• Testosterone cypionate injection (Depo-Testosterone) is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone:

  • Primary hypogonadism (congenital or acquired) - testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchiectomy
  • Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation
    
    

  Limitations of Use: Safety and efficacy of Depo-Testosterone in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Compendial Uses 

• Gender dysphoria (also known as transgender and gender diverse (TGD) persons)

Testosterone cypionate injection, a Schedule III controlled substance, is available as Depo-Testosterone (Pharmacia and Upjohn Company) or in generic formulation (Slayback Pharma LLC). 

Testosterone is an endogenous androgen which is responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Low serum testosterone concentrations due to inadequate secretion of testosterone is associated with male hypogonadism. Symptoms include decreased sexual desire with or without impotence, fatigue, and mood disturbances. Male hypogonadism has two main etiologies, primary hypogonadism, which is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, and secondary hypogonadism, which is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH) (Slayback Pharma, 2022).

Testosterone cypionate is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate or women who are pregnant, as testosterone may cause fetal harm. Label warnings and precautions include the following:

• Polycythemia
• Cardiovascular risk: may increase the risk of major adverse cardiovascular events (MACE)
• Worsening of benign prostatic hyperplasia (BPH) and potential risk of prostate cancer
• Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products
• Abuse of testosterone 
• Potential for adverse effects on spermatogenesis, may cause azoospermia
• Edema, with or without congestive heart failure (CHF), may occur in patients with pre-existing cardiac, renal, or hepatic disease
• Sleep apnea in those with risk factors
• Lipid changes
• Adverse effects on bone maturation, may result in acceleration of bone age and premature closure of epiphyses in pediatric patients which may result in compromised adult stature. Monitor the effect on bone maturation by assessing bone age of the wrist and hand every 6 months.

The most common adverse reactions (4% or more) are injection site erythema and injection site reaction. Other adverse reactions include polycythemia, gynecomastia, headache, and depression.

Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and prostatic carcinoma. The safety and effectiveness in pediatric patients below the age of 12 years have not been established. Due to lack of controlled studies in women and the potential for virilizing effects, Testosterone Cypionate Injection (Slayback Pharma LLC) is not indicated for use in women.

Other Indications

Coronary Heart Disease / Heart Failure 

Toma et al (2012) stated that low testosterone is an independent predictor of reduced exercise capacity and poor clinical outcomes in patients with heart failure (HF). These investigators examined if testosterone therapy improves exercise capacity in patients with stable chronic HF. They searched Medline, Embase, Web of Science, and Cochrane Central Register of Controlled Trials (1980 to 2010). Eligible studies included randomized controlled trials (RCTs) reporting the effects of testosterone on exercise capacity in patients with HF. Reviewers determined the methodological quality of studies and collected descriptive, quality, and outcome data. A total of 4 trials (n = 198; men, 84 %; mean age of 67 years) were identified that reported the 6-minute walk test (2 RCTs), incremental shuttle walk test (2 RCTs), or peak oxygen consumption (2 RCTs) to assess exercise capacity after up to 52 weeks of treatment. Testosterone therapy was associated with a significant improvement in exercise capacity compared with placebo. The mean increase in the 6-minute walk test, incremental shuttle walk test, and peak oxygen consumption between the testosterone and placebo groups was 54.0 m (95 % confidence interval [CI]: 43.0 to 65.0 m), 46.7 m (95 % CI: 12.6 to 80.9 m), and 2.70 ml/kg per min (95 % CI: 2.68 to 2.72 mL/kg per min), respectively. Testosterone therapy was associated with a significant increase in exercise capacity as measured by units of pooled SDs (net effect, 0.52 SD; 95 % CI: 0.10 to 0.94 SD). No significant adverse cardiovascular events were noted. The authors concluded that given the unmet clinical needs, testosterone appears to be a promising therapy to improve functional capacity in patients with HF. They stated that adequately powered RCTs are required to assess the benefits of testosterone in this high-risk population with regard to quality of life, clinical events, and safety.

Budoff and colleagues (2017) stated that recent studies have yielded conflicting results as to whether testosterone treatment increases cardiovascular risk. In a double-blinded, placebo-controlled, multi-center trial, these researchers tested the hypothesis that testosterone treatment of older men with low testosterone slows progression of non-calcified coronary artery plaque volume. Participants were 170 of 788 men aged 65 years or older with an average of 2 serum testosterone levels lower than 275 ng/dL (82 men assigned to placebo, 88 to testosterone) and symptoms suggestive of hypogonadism who were enrolled in the Testosterone Trials between June 24, 2010, and June 9, 2014. Testosterone gel, with the dose adjusted to maintain the testosterone level in the normal range for young men, or placebo gel for 12 months. The primary outcome was non-calcified coronary artery plaque volume, as determined by coronary computed tomographic angiography; secondary outcomes included total coronary artery plaque volume and coronary artery calcium score (range of 0 to greater than 400 Agatston units, with higher values indicating more severe atherosclerosis). Of 170 men who were enrolled, 138 (73 receiving testosterone treatment and 65 receiving placebo) completed the study and were available for the primary analysis. Among the 138 men, the mean (SD) age was 71.2 (5.7) years, and 81 % were white. At baseline, 70 men (50.7 %) had a coronary artery calcification score higher than 300 Agatston units, reflecting severe atherosclerosis. For the primary outcome, testosterone treatment compared with placebo was associated with a significantly greater increase in non-calcified plaque volume from baseline to 12 months (from median values of 204 mm3 to 232 mm3 versus 317 mm3 to 325 mm3, respectively; estimated difference, 41 mm3; 95 % CI: 14 to 67 mm3; p = 0.003). For the secondary outcomes, the median total plaque volume increased from baseline to 12 months from 272 mm3 to 318 mm3 in the testosterone group versus from 499 mm3 to 541 mm3 in the placebo group (estimated difference, 47 mm3; 95 % CI: 13 to 80 mm3; p = 0.006), and the median coronary artery calcification score changed from 255 to 244 Agatston units in the testosterone group versus 494 to 503 Agatston units in the placebo group (estimated difference, -27 Agatston units; 95 % CI: -80 to 26 Agatston units). No major adverse cardiovascular events occurred in either group. The authors concluded that among older men with symptomatic hypogonadism, treatment with testosterone gel for 1 year compared with placebo was associated with a significantly greater increase in coronary artery non-calcified plaque volume, as measured by coronary computed tomographic angiography. Moreover, they stated that larger studies are needed to understand the clinical implications of this finding.

Zhao and colleagues (2018) noted that higher androgen and lower estrogen levels are associated with cardiovascular disease (CVD) risk factors in women.  However, studies on sex hormones and incident CVD events in women have yielded conflicting results.  These investigators evaluated the associations of sex hormone levels with incident CVD, coronary heart disease (CHD), and heart failure (HF) events among women without CVD at baseline.  These researchers studied 2,834 post-menopausal women participating in the MESA (Multi-Ethnic Study of Atherosclerosis) with testosterone, estradiol, dehydroepiandrosterone, and sex hormone binding globulin (SHBG) levels measured at baseline (2000 to 2002).  They used Cox hazard models to evaluate associations of sex hormones with each outcome, adjusting for demographics, CVD risk factors, and hormone therapy use.  The mean age was 64.9 ± 8.9 years.  During 12.1 years of follow-up, 283 CVD, 171 CHD, and 103 HF incident events occurred.  In multivariable-adjusted models, the hazard ratio (HR; 95 % CI) associated with 1 SD greater log-transformed sex hormone level for the respective outcomes of CVD, CHD, and HF were as follows: total testosterone: 1.14 (95 % CI: 1.01 to 1.29), 1.20 (95 % CI: 1.03 to 1.40), 1.09 (95 % CI: 0.90 to 1.34); estradiol: 0.94 (95 % CI: 0.80 to 1.11), 0.77 (95 % CI: 0.63 to 0.95), 0.78 (95 % CI: 0.60 to 1.02); and testosterone/estradiol ratio: 1.19 (95 % CI: 1.02 to 1.40), 1.45 (95 % CI: 1.19 to 1.78), 1.31 (95 % CI: 1.01 to 1.70).  Dehydroepiandrosterone and SHBG levels were not associated with these outcomes.  The authors concluded that among post-menopausal women, a higher testosterone/estradiol ratio was associated with an elevated risk for incident CVD, CHD, and HF events, higher levels of testosterone associated with increased CVD and CHD, whereas higher estradiol levels were associated with a lower CHD risk.  Sex hormone levels after menopause were associated with women's increased CVD risk later in life.

Female Sexual Dysfunction / Hypoactive Sexual Desire Disorder

van Anders and colleagues (2005) presented their preliminary clinical experience on the effects of testosterone on hypoactive sexual desire in pre- and postmenopausal women who were compared with an age-matched reference group. The subjects received 100 mg of testosterone cypionate in oil injected intramuscularly monthly for 3 months. The authors measured salivary testosterone and scores on the Sexual Desire Inventory pretreatment and posttreatment. Treated and reference subjects' baseline testosterone was found to be equivalent, however, treated subjects exhibited higher testosterone levels than did reference participants posttreatment. The authors state that treated subjects exhibited lower baseline sexual desire than did reference participants and showed a significant increase in sexual desire posttreatment. The authors concluded that their research "suggests that testosterone may effectively alleviate hypoactive sexual desire, even in women with normal testosterone levels".

Reis and Abdo (2014) evaluated the use of androgens in the treatment of a lack of libido in women, comparing 2 periods, i.e., before and after the advent of the phosphodiesterase type 5 inhibitors.  These researchers also analyzed the risks and benefits of androgen administration.  They searched the Latin-American and Caribbean Health Sciences Literature, Cochrane Library, Excerpta Medica, Scientific Electronic Library Online, and Medline (PubMed) databases using the search terms disfunção sexual feminina/female sexual dysfunction, desejo sexual hipoativo/female hypoactive sexual desire disorder, testosterona/testosterone, terapia androgênica em mulheres/androgen therapy in women, and sexualidade/sexuality as well as combinations thereof.  They selected articles written in English, Portuguese, or Spanish.  After the advent of phosphodiesterase type 5 inhibitors, there was a significant increase in the number of studies aimed at evaluating the use of testosterone in women with hypoactive sexual desire disorder.  However, the risks and benefits of testosterone administration have yet to be clarified.

Cappelletti and Wallen (2016) noted that both estradiol and testosterone have been implicated as the steroid critical for modulating women's sexual desire.  By contrast, in all other female mammals only estradiol has been shown to be critical for female sexual motivation and behavior.  Pharmaceutical companies have invested heavily in the development of androgen therapies for female sexual desire disorders (FSDDs), but today there are still no FDA-approved androgen therapies for women.  Nonetheless, testosterone is currently, and frequently, prescribed off-label for the treatment of low sexual desire in women, and the idea of testosterone as a possible cure-all for female sexual dysfunction remains popular.  These researchers placed the ongoing debate concerning the hormonal modulation of women's sexual desire within a historical context, and reviewed controlled trials of estrogen and/or androgen therapies for low sexual desire in post-menopausal women.  They noted that available studies demonstrated that estrogen-only therapies that produce peri-ovulatory levels of circulating estradiol increase sexual desire in post-menopausal women.  Testosterone at supra-physiological, but not at physiological, levels enhances the effectiveness of low-dose estrogen therapies at increasing women's sexual desire; however, the mechanism by which supra-physiological testosterone increases women's sexual desire in combination with an estrogen remains unknown.  Because effective therapies require supra-physiological amounts of testosterone, it remains unclear whether endogenous testosterone contributes to the modulation of women's sexual desire.  The authors concluded that the likelihood that an androgen-only clinical treatment will meaningfully increase women's sexual desire is minimal, and the focus of pharmaceutical companies on the development of androgen therapies for the treatment of FSDDs is likely misplaced.

Improvement of Cognitive Function In Aging Men

Hua and colleagues (2016) stated that endogenous testosterone in the aging man has been scrutinized extensively in regard to its effects on performance in many cognitive domains, especially verbal fluency, visuo-spatial and visuo-perceptual abilities, memory, and executive function.  Studies of testosterone supplementation have sought to identify potential cognitive improvements in men with and without baseline cognitive impairment, and have had a wide range of results.  The variability in outcomes is likely related, in part, to the lack of consensus on methods for testosterone measurement and supplementation and, in part, to the disparate measures of cognitive function used in RCTs.  Despite the limitations imposed by such inconsistent methods, promising associations have been found between cognition and testosterone supplementation in both eugonadal men and men with low testosterone levels, with and without baseline cognitive dysfunction.  These investigators highlighted the cognitive measures used in and the outcomes of existing studies of testosterone and cognition in aging men.  The authors concluded that that larger studies and a more standardized approach to assessment are needed before one can fully understand and realize sustained benefits from testosterone supplementation in the elderly male population, especially given the substantial increase in testosterone supplementation in clinical practice.

Resnick and associates (2017) examined if testosterone treatment compared with placebo is associated with improved verbal memory and other cognitive functions in older men with low testosterone and age-associated memory impairment (AAMI).  The Testosterone Trials (TTrials) were 7 trials to evaluate the effectiveness of testosterone treatment in older men with low testosterone levels.  The Cognitive Function Trial evaluated cognitive function in all TTrials participants.  In 12 US academic medical centers, a total of 788 men who were 65 years or older with a serum testosterone level less than 275 ng/ml and impaired sexual function, physical function, or vitality were allocated to testosterone treatment (n = 394) or placebo (n = 394).  A subgroup of 493 men met criteria for AAMI based on baseline subjective memory complaints and objective memory performance.  Enrollment in the TTrials began on June 24, 2010; the final participant completed treatment and assessment in June 2014.  Participants received testosterone gel (adjusted to maintain the testosterone level within the normal range for young men) or placebo gel for 1 year.  The primary outcome was the mean change from baseline to 6 months and 12 months for delayed paragraph recall (score range of 0 to 50) among men with AAMI.  Secondary outcomes were mean changes in visual memory (Benton Visual Retention Test; score range of 0 to -26), executive function (Trail-Making Test B minus A; range of -290 to 290), and spatial ability (Card Rotation Test; score range of -80 to 80) among men with AAMI.  Tests were administered at baseline, 6 months, and 12 months.  Among the 493 men with AAMI (mean age of 72.3 years [SD, 5.8]; mean baseline testosterone, 234 ng/dL [SD, 65.1]), 247 were assigned to receive testosterone and 246 to receive placebo.  Of these groups, 247 men in the testosterone group and 245 men in the placebo completed the memory study.  There was no significant mean change from baseline to 6 and 12 months in delayed paragraph recall score among men with AAMI in the testosterone and placebo groups (adjusted estimated difference, -0.07 [95 % CI: -0.92 to 0.79]; p = 0.88).  Mean scores for delayed paragraph recall were 14.0 at baseline, 16.0 at 6 months, and 16.2 at 12 months in the testosterone group and 14.4 at baseline, 16.0 at 6 months, and 16.5 at 12 months in the placebo group.  Testosterone was also not associated with significant differences in visual memory (-0.28 [95 % CI: -0.76 to 0.19]; p = 0.24), executive function (-5.51 [95 % CI: -12.91 to 1.88]; p = 0.14), or spatial ability (-0.12 [95 % CI: -1.89 to 1.65]; p = 0.89).  The authors concluded that among older men with low testosterone and age-associated memory impairment, treatment with testosterone for 1 year compared with placebo was not associated with improved memory or other cognitive functions.

Testosterone Replacement in Prostate Cancer Survivors with Testosterone Deficiency

Valderrabano et al (2023) noted that most men diagnosed with prostate cancer (PCa) today have organ-confined disease and low-risk of disease recurrence following radical prostatectomy (RP).  Testosterone deficiency in PCa survivors contributes to impaired health-related quality of life (HR-QOL); however, testosterone treatment is viewed as a contraindication in this population.  These researchers described the design of the 1st randomized trial to determine the safety and effectiveness of testosterone replacement in men who have undergone RP for non-aggressive PCa and have symptomatic testosterone deficiency.  The Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone Trial is a randomized, placebo-controlled, double-blind, parallel group trial in 142 men, aged 40 year or higher, who have undergone RP for organ-confined PCa, Gleason score of 7 (3+4) or less, Stage pT2, N0, M0 lesions and have symptomatic testosterone deficiency and undetectable prostate specific antigen (PSA) for more than 2 years after surgery.  Eligible participants are randomized to weekly intra-muscular injections of 100-mg testosterone cypionate or placebo for 12 weeks and followed for another 12 weeks.  Primary endpoint is change from baseline in sexual activity.  Secondary outcomes include change in sexual desire, erectile function, energy, lean and fat mass, physical and cognitive performance.  Safety is evaluated by monitoring PSA, lower urinary tract symptoms (LUTS), hemoglobin (Hb), and adverse events (AEs).  The Trial is being carried out at 2 trial sites in Boston, MA and Baltimore, MD.  As of July 30, 2022, 42 participants have been randomized.  No PSA or clinical recurrence has been noted to-date.  Recruitment was slowed by coronavirus disease 2019 (COVID-19)-related closures, slow subsequent ramp-up of research activities, and patient concerns regarding safety of testosterone treatment.  Despite these challenges, participant retention has been high.  The authors concluded that the Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone Trial, a placebo-controlled, randomized trial, will determine if testosterone replacement therapy is safe and effective in correcting symptoms of testosterone deficiency in PCa survivors, and potentially inform clinical practice.

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References