An analysis of testosterone implants for androgen replacement therapy

Handelsman, David J.; Mackey, Maryanne; Howe, Chris; Turner, Leo; Conway, Ann J.

doi:10.1046/j.1365-2265.1997.2521050.x

Cited by 91 publications

(64 citation statements)

References 25 publications

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“…Participants were enrolled when they required re-treatment, consequent on return of their own distinctive symptoms of androgen deficiency [25]. Further details of the participant population have been reported elsewhere [6,25]. The trial was approved by the Human Ethics Review Committee, Sydney South West Area Health Service (Concord zone), and all participants provided a written informed consent before entry.…”

Section: Participantsmentioning

confidence: 99%

“…For example, T pellets implanted at intervals of 6 months have a very high elective continuation rate relative to a cost-minimized choice of alternative T products [6]. More recently, T undecanoate (TU) was developed as an IM injectable depot using an oil vehicle with a 12-week inter-injection interval that greatly 228 npg exceeds older T ester products that typically required a 2-week inter-injection interval [7].…”

Section: Introductionmentioning

confidence: 99%

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Factors influencing time course of pain after depot oil intramuscular injection of testosterone undecanoate

Sartorius¹,

Fennell²,

Spasevska³

et al. 2010

Asian J Androl

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Pain following depot intramuscular (IM) injection of oil vehicle-based drugs has been little studied. This study aimed to determine prospectively the prevalence, determinants, severity and functional consequences of pain during the week after IM injection of 1 000 mg testosterone undecanoate (TU) in a 4-mL castor oil vehicle. Androgendeficient men receiving regular T replacement therapy at an academic andrology clinic were recruited to report pain scores using a coloured visual linear analogue scale at seven times over the first day and daily for a week after a deep IM gluteal injection. The time course and covariables influencing pain scores were analysed by mixed model analysis of variance (ANOVA). Following 168 injections in 125 men, pain was reported by 80% of men, peaking immediately after injection, reaching only moderate severity, lasting 1-2 days and returning to baseline by day 4. The pain required little analgesic use and produced minimal interference in daily activities. The time course of pain scores was reproducible in the 43 men who underwent two consecutive injections. Pain was more severe in men who had an earlier painful injection, but less severe in older and more obese men. There were negligible differences in post-injection pain experience between experienced nurses administering injections. Deep IM gluteal injection of depot TU in 4-mL castor oil is well tolerated and post-injection pain is influenced by earlier painful injection experience, as well as age and obesity.

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Section: Participantsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Factors influencing time course of pain after depot oil intramuscular injection of testosterone undecanoate

Sartorius¹,

Fennell²,

Spasevska³

et al. 2010

Asian J Androl

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“…The standard testosterone dose was provided by subdermal implantation of testosterone pellets (four 200 mg testosterone pellets; Organon Australia Pty Ltd), individually titrated (for timing of re-implantation, typically , 6 monthly) to maintain adequate androgen replacement (18)(19)(20). In men with panhypopituitarism, other pituitary hormones (thyroxine and cortisol) were replaced at stable, standard doses if required.…”

Section: Patients and Study Designmentioning

confidence: 99%

Adequacy of androgen replacement influences bone density response to testosterone in androgen-deficient men

Aminorroaya

Kelleher²,

Conway³

et al. 2005

eur j endocrinol

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Objective: Androgen deficiency (AD) leads to bone loss and contributes to osteoporotic fractures in men. Although low bone mineral density (BMD) in AD men is improved by testosterone replacement, the responses vary between individuals but the determinants of this variability are not well defined. Design and methods: Retrospective review of dual energy X-ray absorptiometry (DEXA) of the lumbar spine and proximal femur in men with established AD requiring regular androgen replacement therapy (ART). After a DEXA scan all men were treated with testosterone implants (800 mg, , 6 month intervals). Patients were classified as having a congenital, childhood, or post-pubertal onset, as well as according to the adequacy of treatment prior to their first DEXA scan as untreated, partially treated or well treated. Results: Men with AD requiring regular ART (n ¼ 169, aged 46.3^1.1 years, range 22 -84 years) underwent a DEXA scan prior to being treated with testosterone implants (800 mg, ,6 month intervals). In cross-sectional analysis at the time of the first DEXA scan untreated men (n ¼ 24) had significantly reduced age-adjusted BMD at all four sites (L1 -L4, femoral neck, Ward's triangle and trochanter). Well-treated men (n ¼ 77) had significantly better age-adjusted BMD at all four sites compared with those who were partially treated (n ¼ 66) or untreated (n ¼ 24) with their ageadjusted BMD being normalized. In a longitudinal assessment of men (n ¼ 60) who had two or more serial DEXA scans, at the second DEXA scan after a median of 3 years, men who were previously partially treated (n ¼ 19) or untreated (n ¼ 11) had proportionately greater improvements in BMD, significantly for Ward's triangle (P ¼ 0.025) and the trochanter (P ¼ 0.044) compared with men (n ¼ 30) previously well treated. Conclusions: The present study demonstrates a positive relationship between adequacy of testosterone replacement and BMD in men with overt organic AD. Additionally, the BMD of well-treated AD men approximates that of age-matched non-AD controls. The greatest BMD gains are made by those who have been either untreated or partially treated, and optimal treatment over time (median 3 years) normalizes BMD to the level expected for healthy men of the same age.European Journal of Endocrinology 152 881-886

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“…34,35 The subcutaneous implants are not associated with high DHT levels, which is desirable when treating older hypogonadal man in whom concerns regarding the prostate gland are of paramount importance. The signi®cance of elevated levels of DHT, which are more common with oral or scrotal administration of T still remains to be clari®ed.…”

Section: Other Preparationsmentioning

confidence: 99%

Testosterone replacement: when is there a role?

Morales

2000

Int J Impot Res

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Hypogonadism is an uncommon cause of erectile dysfunction. Unfortunately, hypogonadal states in adult males are dif®cult to diagnose on purely clinical grounds and it is necessary to seek biochemical support. The simplest way to establish the diagnosis of hypogonadism is by determination of serum testosterone levels. Several methods exist but total testosterone determination plus assessment of sex hormone-binding globulin or bio-available testosterone appear to be the most reliable and accessible. Once a diagnostic of hypogonadism has been established in a man with erectile dif®culties, a trial of androgen supplementation is warranted if no contraindications exist. Knowledgeable monitoring is essential. In the absence of an adequate response, co-morbidities should be diligently sought out. In the absence of reliable guidelines for androgen administration to patients with erectile failure, a set of recommendations are provided.

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An analysis of testosterone implants for androgen replacement therapy

Cited by 91 publications

References 25 publications

Factors influencing time course of pain after depot oil intramuscular injection of testosterone undecanoate

Factors influencing time course of pain after depot oil intramuscular injection of testosterone undecanoate

Adequacy of androgen replacement influences bone density response to testosterone in androgen-deficient men

Testosterone replacement: when is there a role?

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