Active — Not RecruitingNot Applicable

Cardiometabolic Health in Transgender Males

United States90 participantsStarted 2021-09-30

Plain-language summary

Transgender individuals are those with a gender identity opposite the sex they were assigned at birth. Approximately 1% of the population is transgender, equating to \~60,000 transgender Wisconsinites. A transgender boy or man is someone with a 46,XX karyotype and typical female genitalia but a male gender identity and desire for more male-typical gender expression. Gender-affirming testosterone (hormonal) treatment (GAHT) is the cornerstone of masculinizing therapy for transgender men and boys, resulting in estrogen (E2) suppression and circulating testosterone (T) levels equivalent to cisgender males. Historically, GAHT was initiated after an E2-driven puberty, but the last decade has seen an explosion of referrals for GAHT in transboys, many of whom are exposed to only low E2 levels before puberty is halted with blocker therapy. Knowledge of risks incurred by GAHT rely on low-quality studies, precluding conclusive assessment of GAHT's long-term impact on cardiometabolic outcomes. Data on transboys receiving GAHT before completion of E2-driven puberty are sparser and no studies have addressed mechanisms by which GAHT may affect vascular physiology. The investigators aim to determine the cardiometabolic impact of GAHT in transboys/men and to determine if any differences identified are mechanistically dependent on the timing of GAHT relative to puberty.

Who can participate

Age range12 Years – 30 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Sex assigned female at birth and a male gender identity (i.e., transgender male)
✓. Aged 12-30 years
✓. Have a care provider in the Children's Wisconsin Gender Health Clinic or Froedtert Hospital Inclusion Clinic who has determined the individual meets clinical criteria to start testosterone therapy and plans to initiate this therapy
✓. Naïve to testosterone or other masculinizing medical therapy
✓. Cisgender girls/women and transgender boys/men of child-bearing potential (defined as having achieved menarche (first menses), excluding those who have had a hysterectomy or are on GnRH agonist therapy (puberty blockers)) must be willing to use effective birth control (which may include abstinence)) from screening visit until final study visit
✓. Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is \< 18 years of age
✓. Gender identity concordant with sex assigned at birth (i.e., cisgender)
✓. Aged 12-30 years

What they're measuring

Change in vascular endothelial function after one year of gender-affirming testosterone therapy as measured by brachial artery ultrasound flow-mediated dilation

Timeframe: 1 year from baseline study visit

Change in vascular endothelial function after one year of gender-affirming testosterone therapy as measured by by blood pressure.

Timeframe: 1 year from baseline study visit

Change in vascular endothelial function after one year of gender-affirming testosterone therapy as measured by circulating markers of endothelial activation as measured by plasma analysis

Timeframe: 1 year from baseline study visit

Trial details

NCT IDNCT04977765

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-03-31

View on ClinicalTrials.gov More Transgender trials

Plain-language summary

Who can participate

Age range12 Years – 30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Sex assigned female at birth and a male gender identity (i.e., transgender male)
✓. Aged 12-30 years
✓. Have a care provider in the Children's Wisconsin Gender Health Clinic or Froedtert Hospital Inclusion Clinic who has determined the individual meets clinical criteria to start testosterone therapy and plans to initiate this therapy
✓. Naïve to testosterone or other masculinizing medical therapy
✓. Cisgender girls/women and transgender boys/men of child-bearing potential (defined as having achieved menarche (first menses), excluding those who have had a hysterectomy or are on GnRH agonist therapy (puberty blockers)) must be willing to use effective birth control (which may include abstinence)) from screening visit until final study visit
✓. Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is \< 18 years of age
✓. Gender identity concordant with sex assigned at birth (i.e., cisgender)
✓. Aged 12-30 years

What they're measuring

Change in vascular endothelial function after one year of gender-affirming testosterone therapy as measured by brachial artery ultrasound flow-mediated dilation

Timeframe: 1 year from baseline study visit

Change in vascular endothelial function after one year of gender-affirming testosterone therapy as measured by by blood pressure.

Timeframe: 1 year from baseline study visit

Change in vascular endothelial function after one year of gender-affirming testosterone therapy as measured by circulating markers of endothelial activation as measured by plasma analysis

Timeframe: 1 year from baseline study visit