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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Immune response change

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
1 Previous Clinical Trials
146 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
454 Previous Clinical Trials
90,716 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment offer opportunities for patient participation?

"Affirmative. The latest information posted on clinicaltrials.gov indicates that this medical trial, which was first publicized on June 17th 2020, is actively recruiting patients. Currently, 60 participants are sought-after from a single location."

Answered by AI

Are there any comparable analyses that have centered on Healthy Volunteer Female participants?

"Currently, there are 72 Healthy Volunteer Female clinical trials underway. Of these studies 13 are in Phase 3 of the trial and majority (248) are conducted at Sao Luis, MA."

Answered by AI

How many volunteers are participating in this medical research?

"Affirmative. Research published on clinicaltrials.gov implies that this medical investigation is still recruiting individuals, having been initially posted on June 17th 2020 and most recently modified on January 18th 2022. The study seeks to enrol 60 patients across a single site."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
North Carolina
Other
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

I’m a MTF trans woman and have been on estrogen for 13 years. I wish to help with increasing medical knowledge of my community.
PatientReceived 2+ prior treatments
I want to help, and I want to find something to fill out my breast. I want to be bigger and help you as well with your research.
PatientReceived no prior treatments
I want to help and I want to find something to fill out my breast.I want to be more bigger and help you as wellwith your research.
PatientReceived 2+ prior treatments
I’m currently on estrogen and spironolactone. I do have some side effects that I get from taking it. I want to know if this trial offers something that will.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Do I contact them directly to volunteer or do you arrange it? are there any side effects? Is this study drug approved for people to try? How safe is it? Will it negatively effect my hormones replacement therapy?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
2020. "Effect of Gender Affirming Hormone Therapy on Glucose Metabolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04515472.
All > Transgender
~0 spots leftby Jun 2024
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