Subcutaneous testosterone effective HT for transgender male, gender-diverse youths
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Subcutaneous testosterone was effective in allowing transgender male and gender-diverse youths to reach recommended testosterone levels and stop menses, with few severe adverse events, according to findings published in Transgender Health.
“Generic forms of injectable testosterone (cypionate and enanthate) are approved only for intramuscular use, even though both formulations have been used off-label for subcutaneous application in transgender care for years,” Sarah E. Laurenzano, MD, a pediatric endocrinologist at the University of New Mexico and former fellow in pediatric endocrinology at the University of California, San Diego, and Maja Marinkovic, MD, associate clinical professor in the department of pediatric endocrinology at the University of California, San Diego, and medical co-director of the Center for Gender Affirming Care at Rady Children’s Hospital-San Diego, told Healio. “Providers, patients and their families may be reluctant to attempt off-label use, and our research findings may help change that. Confirming safety and efficacy of subcutaneous testosterone may increase compliance as compared to the deeper and often more painful intramuscular injections.”
Laurenzano, Marinkovic and colleagues conducted a retrospective study analyzing subcutaneous testosterone as gender-affirming HT in transgender males and gender-diverse youths at Rady Children’s Hospital-San Diego. A total of 119 participants who were younger than 21 years when starting testosterone and received testosterone for at least 6 months between August 2012 and February 2020 were included. Demographic information was documented at the start of HT. Researchers obtained BMI, BMI z scores, testosterone levels and laboratory levels at the start of HT as well as at follow-up, defined as the last date testosterone levels were checked.
Recommended levels reached, menses cessation for most
Of the study population, 79% received 100 mg to 200 mg of testosterone monthly at last follow-up, and 18% received 240 mg to 320 mg monthly. HT started with 25 mg to 50 mg biweekly doses and were increased every 3 to 6 months based on testosterone levels, patient preference and the timing of follow-up. By the end of follow-up, 70% were receiving weekly injections.
For those receiving at least 200 mg of testosterone monthly, the mean total testosterone level was 460 ng/dL and the mean free testosterone level was at 92 pg/mL. There was no difference in testosterone levels between those on weekly dosing and those still receiving biweekly doses at last follow-up. Of 78 participants with data on menses status, all but two had cessation of menses with a 200 mg monthly dose of subcutaneous testosterone, and 53.9% had cessation of menses with a monthly dose of 140 mg.
Participants had a mean BMI of 25.71 kg/m2 at follow-up, an increase of 0.86 kg/m2 from baseline. For 95 youths with available BMI z scores, there was a decrease from 0.56 at baseline to 0.5 at follow-up. There was no association between BMI z score and final subcutaneous testosterone dose.
“Weight gain related to testosterone treatment has been a concern for care providers and patients,” Laurenzano and Marinkovic said. “One, perhaps unexpected, but reassuring finding from our research was that our study population did not have significant increase in BMI z scores by the end of study period.”
A mean decrease in HDL of 6.42 mg/dL was observed from baseline to follow-up. Participants had an increase in hematocrit from baseline to follow-up, with an increase in hematocrit observed as testosterone dosage increased (P = .024).
Serious adverse events rare
At baseline, 57.5% of participants had documented acne, with it reported as mild to moderate in most. Progression of acne was found in 64.7% of participants during HT. No one stopped HT due to acne. There were also mild injection site reactions for 14 participants, of whom only four changed therapy in some way. There were no reports of hypertension or transaminitis connected to subcutaneous testosterone, and only one report of worsening dyslipidemia.
“No subjects had to stop subcutaneous testosterone because of serious adverse effects on blood pressure, acne, transaminases, lipid profile or hematocrit,” the researchers wrote. “Overall, tolerance of subcutaneous testosterone was very good. We recommend, based on our extensive experience, that providers consider subcutaneous testosterone as an excellent alternative to intramuscular testosterone for initiation and maintenance of gender-affirming HT in transgender male and gender-diverse youth.”
For more information:
Maja Marinkovic, MD, can be reached at mmarinkovic@rchsd.org.
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