TransgenderBIVATRANSNCT07481942

Body Composition Assessment in Transgender Population.

An observational study of Transgender, run by Celia Bañuls at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 14 years and older, women only
Conditions the study is for: Transgender
What is being tested?: gender affirming hormone therapy
Type of treatment: Injection or infusion
How many people: 70 participants
Where: 1 siteSpain
Study dates: 1 Jan 2017to 31 Oct 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 years and older
Women only
No healthy volunteers
Child, Adult, Older adult

Study population: Participants were recruited from the Gender Identity Unit of the Department of Endocrinology and Nutrition at University Hospital Doctor Peset (Valencia, Spain). All individuals underwent psychological evaluation by an experienced sexologist, who confirmed gender dysphoria according to DSM-V criteria, and prior to inclusion had been approved for gender-affirming medical intervention.

Who may be able to join

Transgender men with confirmed gender dysphoria according to DSM-V criteria by an experienced sexologist.
Testosterone-naïve status
≥14 years
Absence of prior or planned mastectomy or genital surgery during the study period

Who cannot join

Diagnosed eating disorders, severe illness, neuromuscular or malignant disease, cardiovascular disease, and/or diabetes mellitus
Conditions contraindicating bioelectrical impedance analysis (pregnancy, lactation, or pacemaker)
Started GAHT prior to inclusion.

Trial locations and contacts

1 site in 1 country.

Spain1 site

FISABIO
Valencia, Valencia, 46020

Other trials in Spain

About this study

Official title: Body Composition Adaptations Following Initiation of Gender-Affirming Hormone Therapy in Transgender Populations.

Gender-affirming hormone therapy (GAHT) is a fundamental component of medical transition in transgender men, promoting body composition changes that align physical characteristics with gender identity and alleviate gender dysphoria. In adults, GAHT typically involves testosterone administration, whereas adolescents may receive gonadotropin-releasing hormone agonists to suppress puberty before initiating testosterone.

Despite its general safety when appropriately monitored, findings on GAHT-related changes in body composition and potential cardiovascular implications are inconsistent. Accurate assessment of skeletal muscle mass and fat redistribution is clinically relevant, as conventional anthropometric measures may fail to capture these changes.

This study evaluates body composition changes after one year of testosterone therapy in transgender men using bioelectrical impedance vector analysis (BIVA), and explores the utility of muscle ultrasound as an accessible tool for monitoring skeletal muscle and potential differences among testosterone formulations.

Read the detailed description

Gender-affirming hormone therapy (GAHT) is a central component of medical transition in transgender men, and aims to induce body composition changes that align physical appearance with gender identity and reduce gender dysphoria. In adults, GAHT typically consists of testosterone administration, whereas, in adolescents, gonadotropin-releasing hormone agonists (GnRHa) may be used to suppress puberty before initiating testosterone. GAHT has been associated with improvements in psychological well-being, social integration, and quality of life, although evidence remains limited due to the lack of randomized clinical trials. Moreover, body composition changes have been linked to psychological health in this population.

GAHT is considered safe when adequately monitored and individualized according to cardiovascular risk profile and pre-existing conditions. However, current evidence regarding its effects on body composition and potential implications for cardiovascular risk is inconsistent. Clinically, it is particularly relevant to determine the extent to which GAHT supports gains in skeletal muscle mass and fat redistribution, given their influence on body satisfaction and cardiometabolic risk. Importantly, relying on basic anthropometric measures such as body weight may lead to an underestimation of cardiovascular risk by failing to capture changes in key body compartments.

Reference techniques such as DXA or magnetic resonance imaging have been used to characterize these changes, although their limited accessibility restricts their routine application in clinical follow-up. In this context, bioelectrical impedance vector analysis (BIVA) and muscle ultrasound emerge as accessible alternatives for assessing skeletal muscle mass. However, the lack of population-specific reference values may hinder interpretation, underscoring the need to develop dedicated standards and validate these methods in transgender populations.

To examine the effect of one year of testosterone treatment on body composition in transgender men, different parameters will be assessed using BIVA. Additionally, the utility of muscle ultrasound as a feasible tool for monitoring skeletal muscle during masculinization will be explored, as well as if there are differences in body composition between different types of testosterone formulations.

Conditions: Transgender
Being tested: gender affirming hormone therapy
Keywords: visceral fat, bioimpedance, cardiovascular risk, body composition, muscular ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gender affirming hormone therapyDrug
Participants will be treated with testosterone according to the World Professional Association for Transgender Health (WPATH) guidelines. Pharmaceutical presentation of testosterone will be consensually chosen by participants together with their endocrinologists. This include 1,000 mg of intramuscularly administered testosterone undecanoate every 6 weeks after initiation of GAHT and then every 12 weeks (and, in case of testosterone undecanoate stock-out, with 200-250 mg of intramuscularly administered testosterone cypionate), or 50 mg/day of transdermic testosterone gel (Tgel), according to European guidelines. For adolescents, GAHT may be combined with puberty suppression using gonadotropin-releasing hormone agonist (GnRHa), when indicated, and these agents will be continued in adults if menses persisted despite testosterone escalation.

Study groups in NCT07481942
Study group	Role	What they receive
Transgender men using transdermic testosterone gel		Transgender men who initiate 50 mg/day of transdermic testosterone gel as gender affirming hormone therapy (according to european guidelines). Receives: Drug: gender affirming hormone therapy
Transgender men using intramuscularly administered testosterone		Transgender men who initiate 1,000 mg of intramuscularly administered testosterone undecanoate every 6 weeks, and then every 12 weeks (and, in case of testosterone undecanoate stock-out, with 200-250 mg of intramuscularly administered testosterone cypionate) as gender affirming hormone therapy (according to european guidelines). Receives: Drug: gender affirming hormone therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Examine the increase in skeletal muscle mass after one year of testosterone treatment on body composition in transgender men using bioelectrical impedance vector analysis.
To assess if there is a significant skeletal muscle mass gain after one year of testosterone treatment, skeletal muscle mass will be predicted using predictive equations with both resistance and resistence measured using bioelectrical impedance vector analysis. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 5 years
Explore the utility of muscle ultrasound as a feasible tool for monitoring skeletal muscle during masculinization hormonal treatment
Muscle ultrasound will be performed on a subsample using a DP-50 Expert Mobile Ultrasound System (Mindray®) equipped with a 5-10 MHz linear transducer. Examinations will be conducted at baseline, 6 months, and 12 months. Participants will be positioned supine with legs extended and instructed to refrain from exercise for at least 30 minutes before testing. Images will be obtained at the midpoint between the anterior superior iliac spine and the patella. Bilateral quadriceps muscle thickness (right and left; RQU and LQU) will be measured as the distance between the superficial and deep aponeuroses. Thickness of the rectus femoris and vastus intermedius will be recorded along the transverse axis. To check if RQU and LQU can predict skeletal muscle mass gain, regression models will be performed (square R coefficient > 0,6). Acceptable sensitivity and specificity from RQU and LQU as predictors of skeletal muscle mass will be considered if their values are above 70%.
Measured: 5 years
Assess significant changes in skeletal muscle mass gain according to type of testosterone formulation used
Skeletal muscle mass gain will be assessed by calculating the difference between final and baseline values obtained from body composition evaluations. Significant differences between types of testosterone formulations will be considered when notable differences in mean values between groups are observed, as determined by a p-value < 0.05 using multiple pairwise comparisons followed by post hoc analysis, with a 95% confidence interval.
Measured: 5 years

Secondary outcomes (8)

Evaluate significant changes in visceral fat after one year of testosterone treatment
Visceral fat will be measured by bioelectrical impedance. It is considered to be high when > 1,1 L. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 4 years
Quantify skeletal muscle mass gain through one year of testosterone treatment
Quantification of skeletal muscle mass gain will be performed by calculating the difference between baseline (prior to treatment) and final (after one year of treatment) values obtained from bioelectrical impedance analysis. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 4 years
Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after one year of testosterone treatment.
Participants will be considered to have achieved an improvement in high-sensitivity C-reactive protein levels if they normalize its value (normality values defined between 0 and 1.69mg/dl).
Measured: 4 years
Evaluate if there is a significant reduction after one year of testosterone treatment in HOMA-IR levels.
The Homeostatic Model Assessment (HOMA-IR) index is calculated by multiplying fasting plasma insulin by fasting glucose and dividing the result by a constant (405 when glucose is expressed in mg/dL). Participants will be considered to have achieved an improvement in high-sensitivity C-reactive protein levels if they normalize its value (normality values defined between 0 and 3,8).
Measured: 4 years
Analyze the changes in ApoB/ApoA1 ratio after one year of gender-affirming hormone therapy.
ApoB and ApoA1 ratio will be calculated using both parameters, in order to assess if there are significant changes in lipid profile in transgender men using testosterone treatment. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 4 years
Evaluate significant changes in anti-mullerian hormone levels after one year of testosterone treatment.
A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 4 years
Evaluate the changes in inhibin B levels after one year of gender-affirming hormone therapy.
A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 4 years
Evaluate significant changes in hand grip strength after one year of testosterone treatment.
Hand grip strength will be measured using a Jamar® Plus+ digital dynamometer in the non-dominant hand. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201731 Oct 2025

First posted19 Mar 2026
Study start1 Jan 2017
Primary completion31 Dec 2024
Study completion31 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for TransgenderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07481942
Sponsor's protocol ID: CEIm:109/16
Acronym: BIVATRANS
Status last verified: Mar 2026
First submitted: 15 Mar 2026
Last updated: 23 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Aranda G, Mora M, Hanzu FA, Vera J, Ortega E, Halperin I. Effects of sex steroids on cardiovascular risk profile in transgender men under gender affirming hormone therapy. Endocrinol Diabetes Nutr (Engl Ed). 2019 Jun-Jul;66(6):385-392. doi: 10.1016/j.endinu.2018.11.004. Epub 2019 Jan 28. English, Spanish.
PubMed 30704917
Waters J, Linsenmeyer W. The impact of gender-affirming hormone therapy on nutrition-relevant biochemical measures. Front Nutr. 2024 Apr 5;11:1339311. doi: 10.3389/fnut.2024.1339311. eCollection 2024.
PubMed 38646103
Lundberg TR, Tryfonos A, Eriksson LMJ, Rundqvist H, Rullman E, Holmberg M, Maqdasy S, Linge J, Leinhard OD, Arver S, Andersson DP, Wiik A, Gustafsson T. Longitudinal changes in regional fat and muscle composition and cardiometabolic biomarkers over 5 years of hormone therapy in transgender individuals. J Intern Med. 2025 Feb;297(2):156-172. doi: 10.1111/joim.20039. Epub 2024 Nov 27.
PubMed 39604308
Leemaqz SY, Kyinn M, Banks K, Sarkodie E, Goldstein D, Irwig MS. Lipid profiles and hypertriglyceridemia among transgender and gender diverse adults on gender-affirming hormone therapy. J Clin Lipidol. 2023 Jan-Feb;17(1):103-111. doi: 10.1016/j.jacl.2022.11.010. Epub 2022 Nov 22.
PubMed 36473821
Auer MK, Ebert T, Pietzner M, Defreyne J, Fuss J, Stalla GK, T'Sjoen G. Effects of Sex Hormone Treatment on the Metabolic Syndrome in Transgender Individuals: Focus on Metabolic Cytokines. J Clin Endocrinol Metab. 2018 Feb 1;103(2):790-802. doi: 10.1210/jc.2017-01559.
PubMed 29216353
Gava G, Mancini I, Cerpolini S, Baldassarre M, Seracchioli R, Meriggiola MC. Testosterone undecanoate and testosterone enanthate injections are both effective and safe in transmen over 5 years of administration. Clin Endocrinol (Oxf). 2018 Dec;89(6):878-886. doi: 10.1111/cen.13821. Epub 2018 Aug 12.
PubMed 30025172
Fu H, Wang L, Zhang W, Lu J, Yang M. Diagnostic test accuracy of ultrasound for sarcopenia diagnosis: A systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2023 Feb;14(1):57-70. doi: 10.1002/jcsm.13149. Epub 2022 Dec 13.
PubMed 36513380
Marin Baselga R, Teigell-Munoz FJ, Porcel JM, Ramos Lazaro J, Garcia Rubio S. Ultrasound for body composition assessment: a narrative review. Intern Emerg Med. 2025 Jan;20(1):23-34. doi: 10.1007/s11739-024-03756-8. Epub 2024 Sep 6.
PubMed 39240412
Spanos C, Bretherton I, Zajac JD, Cheung AS. Effects of gender-affirming hormone therapy on insulin resistance and body composition in transgender individuals: A systematic review. World J Diabetes. 2020 Mar 15;11(3):66-77. doi: 10.4239/wjd.v11.i3.66.
PubMed 32180895
Ford K, Huggins E, Sheean P. Characterising body composition and bone health in transgender individuals receiving gender-affirming hormone therapy. J Hum Nutr Diet. 2022 Dec;35(6):1105-1114. doi: 10.1111/jhn.13027. Epub 2022 May 22.
PubMed 35509260
Klaver M, Dekker MJHJ, de Mutsert R, Twisk JWR, den Heijer M. Cross-sex hormone therapy in transgender persons affects total body weight, body fat and lean body mass: a meta-analysis. Andrologia. 2017 Jun;49(5). doi: 10.1111/and.12660. Epub 2016 Aug 29.
PubMed 27572683
Ceolin C, Scala A, Scagnet B, Citron A, Vilona F, De Rui M, Miscioscia M, Camozzi V, Ferlin A, Sergi G, Garolla A; GIIG group. Body composition and perceived stress levels in transgender individuals after one year of gender affirming hormone therapy. Front Endocrinol (Lausanne). 2024 Nov 28;15:1496160. doi: 10.3389/fendo.2024.1496160. eCollection 2024.
PubMed 39669495
Miroshnychenko A, Ibrahim S, Roldan Y, Kulatunga-Moruzi C, Montante S, Couban R, Guyatt G, Brignardello-Petersen R. Gender affirming hormone therapy for individuals with gender dysphoria aged <26 years: a systematic review and meta-analysis. Arch Dis Child. 2025 May 16;110(6):437-445. doi: 10.1136/archdischild-2024-327921.
PubMed 39855725
Tornese G, Di Mase R, Munarin J, Ciancia S, Santamaria F, Fava D, Candela E, Capalbo D, Ungaro C, Improda N, Diana P, Matarazzo P, Guazzarotti L, Toschetti T, Sambati V, Tamaro G, Bresciani G, Licenziati MR, Street ME, Aversa T, Delvecchio M, Faienza MF, Iughetti L, Calcaterra V, de Sanctis L, Salerno M, Franceschi R. Use of gonadotropin-releasing hormone agonists in transgender and gender diverse youth: a systematic review. Front Endocrinol (Lausanne). 2025 May 14;16:1555186. doi: 10.3389/fendo.2025.1555186. eCollection 2025.
PubMed 40438403
Coleman E, Radix AE, Bouman WP, Brown GR, de Vries ALC, Deutsch MB, Ettner R, Fraser L, Goodman M, Green J, Hancock AB, Johnson TW, Karasic DH, Knudson GA, Leibowitz SF, Meyer-Bahlburg HFL, Monstrey SJ, Motmans J, Nahata L, Nieder TO, Reisner SL, Richards C, Schechter LS, Tangpricha V, Tishelman AC, Van Trotsenburg MAA, Winter S, Ducheny K, Adams NJ, Adrian TM, Allen LR, Azul D, Bagga H, Basar K, Bathory DS, Belinky JJ, Berg DR, Berli JU, Bluebond-Langner RO, Bouman MB, Bowers ML, Brassard PJ, Byrne J, Capitan L, Cargill CJ, Carswell JM, Chang SC, Chelvakumar G, Corneil T, Dalke KB, De Cuypere G, de Vries E, Den Heijer M, Devor AH, Dhejne C, D'Marco A, Edmiston EK, Edwards-Leeper L, Ehrbar R, Ehrensaft D, Eisfeld J, Elaut E, Erickson-Schroth L, Feldman JL, Fisher AD, Garcia MM, Gijs L, Green SE, Hall BP, Hardy TLD, Irwig MS, Jacobs LA, Janssen AC, Johnson K, Klink DT, Kreukels BPC, Kuper LE, Kvach EJ, Malouf MA, Massey R, Mazur T, McLachlan C, Morrison SD, Mosser SW, Neira PM, Nygren U, Oates JM, Obedin-Maliver J, Pagkalos G, Patton J, Phanuphak N, Rachlin K, Reed T, Rider GN, Ristori J, Robbins-Cherry S, Roberts SA, Rodriguez-Wallberg KA, Rosenthal SM, Sabir K, Safer JD, Scheim AI, Seal LJ, Sehoole TJ, Spencer K, St Amand C, Steensma TD, Strang JF, Taylor GB, Tilleman K, T'Sjoen GG, Vala LN, Van Mello NM, Veale JF, Vencill JA, Vincent B, Wesp LM, West MA, Arcelus J. Standards of Care for the Health of Transgender and Gender Diverse People, Version 8. Int J Transgend Health. 2022 Sep 6;23(Suppl 1):S1-S259. doi: 10.1080/26895269.2022.2100644. eCollection 2022.
PubMed 36238954

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Body Composition Adaptations Following Initiation of Gender-Affirming Hormone Therapy in Transgender Populations.
ClinicalTrials.gov ID: NCT07481942
Acronym / sponsor ID: BIVATRANS / CEIm:109/16
Conditions: Transgender
Keywords: visceral fat, bioimpedance, cardiovascular risk, body composition, muscular ultrasound
Study type: Observational
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Celia BañulsUniversity, hospital or other
Study start: 1 Jan 2017 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Oct 2025 (actual)
First posted: 19 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Transgender men using transdermic testosterone gel	–	Drug: gender affirming hormone therapyTransgender men who initiate 50 mg/day of transdermic testosterone gel as gender affirming hormone therapy (according to european guidelines).
Transgender men using intramuscularly administered testosterone	–	Drug: gender affirming hormone therapyTransgender men who initiate 1,000 mg of intramuscularly administered testosterone undecanoate every 6 weeks, and then every 12 weeks (and, in case of testosterone undecanoate stock-out, with 200-250 mg of intramuscularly administered testosterone cypionate) as gender affirming hormone therapy (according to european guidelines).

Who may qualify

Ages: 14 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Participants were recruited from the Gender Identity Unit of the Department of Endocrinology and Nutrition at University Hospital Doctor Peset (Valencia, Spain). All individuals underwent psychological evaluation by an experienced sexologist, who confirmed gender dysphoria according to DSM-V criteria, and prior to inclusion had been approved for gender-affirming medical intervention.

Key inclusion criteria (4 listed)

Transgender men with confirmed gender dysphoria according to DSM-V criteria by an experienced sexologist.
Testosterone-naïve status
≥14 years
Absence of prior or planned mastectomy or genital surgery during the study period

Key exclusion criteria (3 listed)

Diagnosed eating disorders, severe illness, neuromuscular or malignant disease, cardiovascular disease, and/or diabetes mellitus
Conditions contraindicating bioelectrical impedance analysis (pregnancy, lactation, or pacemaker)
Started GAHT prior to inclusion.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
gender affirming hormone therapyParticipants will be treated with testosterone according to the World Professional Association for Transgender Health (WPATH) guidelines. Pharmaceutical presentation of testosterone will be consensually chosen by participants together with their endocrinologists. This include 1,000 mg of intramuscularly administered testosterone undecanoate every 6 weeks after initiation of GAHT and then every 12 weeks (and, in case of testosterone undecanoate stock-out, with 200-250 mg of intramuscularly administered testosterone cypionate), or 50 mg/day of transdermic testosterone gel (Tgel), according to European guidelines. For adolescents, GAHT may be combined with puberty suppression using gonadotropin-releasing hormone agonist (GnRHa), when indicated, and these agents will be continued in adults if menses persisted despite testosterone escalation.	Drug	Transgender men using intramuscularly administered testosterone, Transgender men using transdermic testosterone gel

Primary outcome

Examine the increase in skeletal muscle mass after one year of testosterone treatment on body composition in transgender men using bioelectrical impedance vector analysis.
Time frame: 5 years
To assess if there is a significant skeletal muscle mass gain after one year of testosterone treatment, skeletal muscle mass will be predicted using predictive equations with both resistance and resistence measured using bioelectrical impedance vector analysis. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (<0.05) with a 95% confidence interval.
Explore the utility of muscle ultrasound as a feasible tool for monitoring skeletal muscle during masculinization hormonal treatment
Time frame: 5 years
Muscle ultrasound will be performed on a subsample using a DP-50 Expert Mobile Ultrasound System (Mindray®) equipped with a 5-10 MHz linear transducer. Examinations will be conducted at baseline, 6 months, and 12 months. Participants will be positioned supine with legs extended and instructed to refrain from exercise for at least 30 minutes before testing. Images will be obtained at the midpoint between the anterior superior iliac spine and the patella. Bilateral quadriceps muscle thickness (right and left; RQU and LQU) will be measured as the distance between the superficial and deep aponeuroses. Thickness of the rectus femoris and vastus intermedius will be recorded along the transverse axis. To check if RQU and LQU can predict skeletal muscle mass gain, regression models will be performed (square R coefficient > 0,6). Acceptable sensitivity and specificity from RQU and LQU as predictors of skeletal muscle mass will be considered if their values are above 70%.
Assess significant changes in skeletal muscle mass gain according to type of testosterone formulation used
Time frame: 5 years
Skeletal muscle mass gain will be assessed by calculating the difference between final and baseline values obtained from body composition evaluations. Significant differences between types of testosterone formulations will be considered when notable differences in mean values between groups are observed, as determined by a p-value < 0.05 using multiple pairwise comparisons followed by post hoc analysis, with a 95% confidence interval.

8 secondary outcomes

Evaluate significant changes in visceral fat after one year of testosterone treatment
Time frame: 4 years
Quantify skeletal muscle mass gain through one year of testosterone treatment
Time frame: 4 years
Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after one year of testosterone treatment.
Time frame: 4 years
Evaluate if there is a significant reduction after one year of testosterone treatment in HOMA-IR levels.
Time frame: 4 years
Analyze the changes in ApoB/ApoA1 ratio after one year of gender-affirming hormone therapy.
Time frame: 4 years
Evaluate significant changes in anti-mullerian hormone levels after one year of testosterone treatment.
Time frame: 4 years
Evaluate the changes in inhibin B levels after one year of gender-affirming hormone therapy.
Time frame: 4 years
Evaluate significant changes in hand grip strength after one year of testosterone treatment.
Time frame: 5 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Background: PubMed 30704917Aranda G, Mora M, Hanzu FA, Vera J, Ortega E, Halperin I. Effects of sex steroids on cardiovascular risk profile in transgender men under gender affirming hormone therapy. Endocrinol Diabetes Nutr (Engl Ed). 2019 Jun-Jul;66(6):385-392. doi: 10.1016/j.endinu.2018.11.004. Epub 2019 Jan 28. English, Spanish.
Background: PubMed 38646103Waters J, Linsenmeyer W. The impact of gender-affirming hormone therapy on nutrition-relevant biochemical measures. Front Nutr. 2024 Apr 5;11:1339311. doi: 10.3389/fnut.2024.1339311. eCollection 2024.
Background: PubMed 39604308Lundberg TR, Tryfonos A, Eriksson LMJ, Rundqvist H, Rullman E, Holmberg M, Maqdasy S, Linge J, Leinhard OD, Arver S, Andersson DP, Wiik A, Gustafsson T. Longitudinal changes in regional fat and muscle composition and cardiometabolic biomarkers over 5 years of hormone therapy in transgender individuals. J Intern Med. 2025 Feb;297(2):156-172. doi: 10.1111/joim.20039. Epub 2024 Nov 27.
Background: PubMed 36473821Leemaqz SY, Kyinn M, Banks K, Sarkodie E, Goldstein D, Irwig MS. Lipid profiles and hypertriglyceridemia among transgender and gender diverse adults on gender-affirming hormone therapy. J Clin Lipidol. 2023 Jan-Feb;17(1):103-111. doi: 10.1016/j.jacl.2022.11.010. Epub 2022 Nov 22.
Background: PubMed 29216353Auer MK, Ebert T, Pietzner M, Defreyne J, Fuss J, Stalla GK, T'Sjoen G. Effects of Sex Hormone Treatment on the Metabolic Syndrome in Transgender Individuals: Focus on Metabolic Cytokines. J Clin Endocrinol Metab. 2018 Feb 1;103(2):790-802. doi: 10.1210/jc.2017-01559.
Background: PubMed 30025172Gava G, Mancini I, Cerpolini S, Baldassarre M, Seracchioli R, Meriggiola MC. Testosterone undecanoate and testosterone enanthate injections are both effective and safe in transmen over 5 years of administration. Clin Endocrinol (Oxf). 2018 Dec;89(6):878-886. doi: 10.1111/cen.13821. Epub 2018 Aug 12.
Background: PubMed 36513380Fu H, Wang L, Zhang W, Lu J, Yang M. Diagnostic test accuracy of ultrasound for sarcopenia diagnosis: A systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2023 Feb;14(1):57-70. doi: 10.1002/jcsm.13149. Epub 2022 Dec 13.
Background: PubMed 39240412Marin Baselga R, Teigell-Munoz FJ, Porcel JM, Ramos Lazaro J, Garcia Rubio S. Ultrasound for body composition assessment: a narrative review. Intern Emerg Med. 2025 Jan;20(1):23-34. doi: 10.1007/s11739-024-03756-8. Epub 2024 Sep 6.
Background: PubMed 32180895Spanos C, Bretherton I, Zajac JD, Cheung AS. Effects of gender-affirming hormone therapy on insulin resistance and body composition in transgender individuals: A systematic review. World J Diabetes. 2020 Mar 15;11(3):66-77. doi: 10.4239/wjd.v11.i3.66.
Background: PubMed 35509260Ford K, Huggins E, Sheean P. Characterising body composition and bone health in transgender individuals receiving gender-affirming hormone therapy. J Hum Nutr Diet. 2022 Dec;35(6):1105-1114. doi: 10.1111/jhn.13027. Epub 2022 May 22.
Background: PubMed 27572683Klaver M, Dekker MJHJ, de Mutsert R, Twisk JWR, den Heijer M. Cross-sex hormone therapy in transgender persons affects total body weight, body fat and lean body mass: a meta-analysis. Andrologia. 2017 Jun;49(5). doi: 10.1111/and.12660. Epub 2016 Aug 29.
Background: PubMed 39669495Ceolin C, Scala A, Scagnet B, Citron A, Vilona F, De Rui M, Miscioscia M, Camozzi V, Ferlin A, Sergi G, Garolla A; GIIG group. Body composition and perceived stress levels in transgender individuals after one year of gender affirming hormone therapy. Front Endocrinol (Lausanne). 2024 Nov 28;15:1496160. doi: 10.3389/fendo.2024.1496160. eCollection 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Transgender, run by Celia Bañuls at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Examine the increase in skeletal muscle mass after one year of testosterone treatment on body composition in transgender men using bioelectrical impedance vector analysis. (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07481942, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.