Safety aspects of 36 months of administration of long-acting intramuscular testosterone undecanoate for treatment of female-to-male transgender individuals
Abstract
DESIGN: Testosterone treatment is essential for the induction and maintenance of virilization of female-to-male (FTM) transsexuals. Aim To test the safety of a novel testosterone preparation for this purpose. METHODS: Parenteral long-acting testosterone undecanoate (TU) was administered to 17 FTM transsexuals over 36 months. Observations were made while subjects received treatment. RESULTS: Serum testosterone rose from 0.50+/-0.25 to 6.2+/-1.3 ng/ml at 6 months and remained stable thereafter. The testosterone profiles were largely identical with those in hypogonadal receiving TU. There were no side effects. Over the 36 months of the study, there was a small but significant decrease in plasma cholesterol (from 218+/-47 to 188+/-42 mg/dl) and low-density lipoprotein-cholesterol (from 139+/-48 to 139+/-48 mg/dl), while plasma levels of high-density lipoprotein-cholesterol and triglycerides did not change significantly. Liver enzymes did not change during treatment. There was an increase of both levels in hemoglobin (from 13.6+/-1.2 to 16.0+/-1.5 g/dl) and hematocrit (from 41+/-4 to 46+/-4) upon administration but they remained almost without exception within the physiological range. No special measures were needed. Breast and gonads/internal genitalia did not show pathological changes over the observation period. CONCLUSION: This study reports that TU is suited for induction of virilization in FTM transsexuals without significant side effects over a longer term.
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Transmen receiving testosterone treatment at replacement doses to create adult male circulating testosterone concentrations exhibit increases in circulating hemoglobin to male levels.
“Corroborative findings are available from studies of transmen (F2M transgender), that is, natal females who subsequently receive testosterone treatment at replacement doses to create adult male circulating testosterone concentrations, who exhibit increases in circulating hemoglobin to male levels [reviewed in (132–134)].”
From Circulating Testosterone as the Hormonal Basis of Sex Differences in Athletic Performance (2018) · cites this paper as [134]
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Qian, R., & Safer, J. D. (2020) · Elsevier eBooks · doi:10.1016/b978-0-323-49642-1.00005-3 · Cited by 1 · see citing works
Testosterone in Transgender Population
Cocchetti, C., & Fisher, A. D. (2021) · Springer eBooks · doi:10.1007/978-3-030-77111-9_9 · Cited by 1 · see citing works
Conundrums in the Medical Treatment of Transgender Persons
Milionis, C., Koukkou, E. G., & Ilias, Ι. (2022) · Endocrine Metabolic & Immune Disorders - Drug Targets · doi:10.2174/1871530322666220223161227 · Cited by 1 · see citing works
Costa, J. A. D. N., Silva, G. A. S. D., Nunes, É. F. C., & Nobre, A. H. (2020) · Revista Brasileira de Saúde Funcional · doi:10.25194/rebrasf.v8i1.1201
Hormone Therapy in Transgender Men
T'Sjoen, G. G., & Defreyne, J. (2022) · doi:10.1093/med/9780198870197.003.0200
Lipid status in transgender patients receiving cross-sex gonadal hormone therapy for 6 months
Jovanović, N., & Vujović, S. (2023) · Medicinski podmladak · doi:10.5937/mp74-35334
Gender-Affirming Hormone Therapy
Swetlitz, N., & Shin, T. (2025) · Springer eBooks · doi:10.1007/978-3-031-82884-3_6
Joseph, S., Ubba, V., Kalim, R., Gunaydin, S., Dass, M., Waheed, D., Hilovsky, D. L., Hartsell, J., Shpargel, J., Liu, X., et al. (2026) · Journal of Lipid Research · doi:10.1016/j.jlr.2026.101031
- Authors
- Jacobeit, J. W., Gooren, L. J., & Schulte, H. M.
- Affiliations
- Endokrinologikum (DE)
- ORCID
- Gooren, L J
- Venue
- European Journal of Endocrinology
- Publisher
- Oxford University Press (OUP)
- Published
- 2009-11
- Volume
- 161
- Issue
- 5
- Pages
- 795-798
- ISSN
- 0804-4643 (ISSN-L)
- 1479-683X
- OpenAlex
- W2156966779
- Cited by
- 73
- References
- 27
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 6 · 2023: 7 · 2022: 8 · 2021: 7 · 2020: 4 · 2019: 3 · 2018: 7 · 2017: 8 · 2016: 1 · 2015: 2 · 2014: 4 · 2013: 1 · 2012: 1
- FWCI
- 2.18
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Endocrinology (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Social Sciences › Psychology › Social Psychology › LGBTQ Health, Identity, and Policy
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Sexual Differentiation and Disorders
- Keywords
- testosterone undecanoate, female-to-male transsexuals, hormone replacement therapy, masculinization, treatment safety, hypogonadism, serum cholesterol, liver enzymes, hemoglobin, adverse effects
- MeSH terms
- Adult, Alanine Transaminase, Aspartate Aminotransferases, Cholesterol, Female, Hematocrit, Glycated Hemoglobin, Humans, Injections, Intramuscular, Middle Aged, Testosterone, Transsexualism, Triglycerides, Statistics, Nonparametric, Testosterone Congeners, Young Adult
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