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Hormone Therapy

Hormone Therapy for Transgender Individuals

Phase < 1
Recruiting
Led By Devjit Tripathy, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable hormone treatment (estrogen or testosterone) for at least 6 months
Healthy volunteers: healthy male or female
Must not have
For healthy volunteers, not current treatment with estrogen or testosterone
Anemia with hemoglobin (Hb) <11.0 hematocrit (Hto) < 34 and Glomerular Filtration rate (GFR) <30
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of estrogen and testosterone therapy on insulin sensitivity and beta cell function in transgender people.

Who is the study for?
This trial is for transgender individuals who have been on stable hormone therapy (estrogen or testosterone) for at least 6 months and do not have diabetes. Healthy male and female volunteers can also participate, provided they are not currently treated with hormones.
What is being tested?
The study examines the effects of estrogen in transwomen on insulin sensitivity and immune response, as well as the impact of testosterone in transmen on glucose metabolism. It involves a Botnia Clamp procedure and temporary withdrawal from Gender Affirming Hormone Therapy.
What are the potential side effects?
Potential side effects may include changes in blood sugar levels due to hormone therapy adjustment. The Botnia Clamp might cause discomfort where it attaches to the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable hormone treatment for at least 6 months.
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I am a healthy individual.
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I am a transgender woman.
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I am not diabetic with normal blood sugar levels.
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I am a female-to-male transgender individual.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently taking estrogen or testosterone.
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I have anemia with low hemoglobin and kidney function.
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I have been diagnosed with diabetes.
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I am FTM transgender and have not had a recent heart attack or stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effects of Chronic estrogen therapy on insulin secretion
Effects of Chronic estrogen therapy on insulin sensitivity
Effects of Chronic testosterone therapy on insulin secretion
+1 more
Secondary study objectives
Immune response change

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Active Control
Group I: Healthy Volunteer MaleActive Control1 Intervention
Healthy male currently on no testosterone treatment
Group II: Healthy Volunteer FemaleActive Control1 Intervention
Healthy female currently on no estrogen treatment
Group III: MTF groupActive Control2 Interventions
MTF transgender currently on estrogen treatment
Group IV: FTM groupActive Control2 Interventions
FTM transgender group currently on testosterone treatment

Find a Location

Who is running the clinical trial?

Foundation for advancing Veterans Health Research (FAVHR)AMBIG
Foundation for Advancing Veterans' Health ResearchOTHER
2 Previous Clinical Trials
266 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
477 Previous Clinical Trials
92,910 Total Patients Enrolled
Devjit Tripathy, MDPrincipal InvestigatorUniversity of Texas Health San Antonio
3 Previous Clinical Trials
61 Total Patients Enrolled

Media Library

Gender Affirming Hormone Therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04515472 — Phase < 1
Transgender Research Study Groups: Healthy Volunteer Male, Healthy Volunteer Female, MTF group, FTM group
Gender Affirming Hormone Therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04515472 — Phase < 1
Transgender Patient Testimony for trial: Trial Name: NCT04515472 — Phase < 1
~5 spots leftby Jun 2025
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