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NCT04977765 · ClinicalTrials.gov registry record

Cardiometabolic Health in Transgender Males

A clinical trial of Transgenderism and Transgender, sponsored by Medical College of Wisconsin.

Active
Registry status
90
Enrollment target
1
Study location

NCT04977765: Active study of Transgenderism and Transgender, sponsored by Medical College of Wisconsin.

NCT04977765 is a study of Transgenderism and Transgender that is active but no longer recruiting, run by Medical College of Wisconsin. The registered enrollment target is 90 participants, above the 52-participant average among 5 other Transgenderism trials with a reported enrollment target (73% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04977765, a study of Transgenderism and Transgender, is active but no longer recruiting, sponsored by Medical College of Wisconsin.

ACTIVE NOT RECRUITING
Registry status
90 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Investigators will examine the effects of gender-affirming testosterone therapy on in vivo endothelial function by brachial artery ultrasound flow-mediated dilation across study visits.

Study Locations (1)

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2021-09-30
Est. Completion 2027-08-01
Medical College of Wisconsin

447 total trials

What the registry record for NCT04977765 still lists

NCT04977765 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 52-participant average among 5 other Transgenderism trials with a reported enrollment target (73% higher).

The record links to 2 conditions, with Transgenderism appearing as the primary indexed condition, and to 0 interventions.

NCT04977765 reports a single indexed study location in Wisconsin.

Frequently Asked Questions

What is clinical trial NCT04977765 about?

NCT04977765 is a clinical study titled "Cardiometabolic Health in Transgender Males". 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...

What is the current status of trial NCT04977765?

This trial is currently active not recruiting. The enrollment target is 90 participants. The study started on 2021-09-30. Estimated completion is 2027-08-01.

What conditions does trial NCT04977765 study?

This clinical trial studies the following conditions: Transgenderism, Transgender.

Who is sponsoring clinical trial NCT04977765?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04977765 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04977765, the US trial registry maintained by the National Library of Medicine. NCT04977765 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.