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Hormone Therapy
Estradiol Therapy for Transgender Women (TREAT Trial)
Phase 2
Recruiting
Led By Ginger Nicol, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline total testosterone level at 6,12,18, and 24 months
Awards & highlights
TREAT Trial Summary
This trial is testing whether estrogen is an effective and safe medication for transgender women, and whether it suppresses testosterone levels.
Who is the study for?
This trial is for transgender female patients aged 18-30 who are eligible and ready for gender-affirming hormone therapy, seen at the Washington University Transgender Center. It's not open to those with a history of liver disease, dyslipidemia needing treatment, BMI over 30, or current smokers.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of estrogen treatments in suppressing testosterone among transgender females. Participants will receive either spironolactone pills or transdermal patches while monitoring hormone and metabolic markers.See study design
What are the potential side effects?
Possible side effects include changes in blood pressure from spironolactone, skin irritation from patches, shifts in metabolic markers which could affect energy levels and weight, as well as potential increases in pro-thrombotic markers that might raise clotting risks.
TREAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline homa-ir at 6,12,18, and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline homa-ir at 6,12,18, and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Degree of testosterone suppression by measuring total testosterone level in transgender female patients undergoing hormonal affirming therapy
Secondary outcome measures
Coagulation factors II, IX, XI, Protein C, Protein S, von Willebrand factor, and activated protein C resistance in transgender female patients undergoing
Homeostatic Model Assessment for Insulin Resistance
Llipid panel
+1 moreTREAT Trial Design
3Treatment groups
Active Control
Group I: Twice daily sublingual estradiol plus spironolactoneActive Control5 Interventions
Starting dose will be 1 mg twice daily Plan to increase every month by 2 mg daily divided BID Goal is to achieve serum estradiol level between 100-200 pg/mL mL and to suppress testosterone to cisgender female levels
All patients will also receive spironolactone. Spironolactone will be started at 50 mg daily and will increase to standard dose.
Spironolactone will be started at 50 mg daily and will increase to standard dose.
Group II: Daily sublingual estradiol plus spironolactoneActive Control5 Interventions
Starting dose will be 2 mg daily Plan to increase every month by 2 mg daily Goal is to achieve serum estradiol level between 100-200 pg/mL mL and to suppress testosterone to cisgender female levels.
All patients will also receive spironolactone. Spironolactone will be started at 50 mg daily and will increase to standard dose.
Spironolactone will be started at 50 mg daily and will increase to standard dose.
Group III: Transdermal estradiol plus spironolactoneActive Control5 Interventions
Starting dose will be 100 mcg/24hrs Plan to increase by 100 mcg/24hrs every month to a max dose of 400 mcg/24hrs Goal is to achieve a serum estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
All patients will also receive spironolactone. Spironolactone will be started at 50 mg daily and will increase to standard dose.
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,609 Total Patients Enrolled
Ginger Nicol, MDPrincipal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
309 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Twice daily sublingual estradiol plus spironolactone
- Group 2: Daily sublingual estradiol plus spironolactone
- Group 3: Transdermal estradiol plus spironolactone
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the risks associated with taking Daily sublingual estradiol plus spironolactone?
"There is both clinical data supporting the efficacy of this medication as well as multiple rounds of safety data, so it received a score of 3."
Answered by AI
What are some common medical conditions that estradiol and spironolactone help to alleviate?
"The following medical conditions can be treated using a combination of estradiol and spironolactone: primary hyperaldosteronism, cirrhosis of the liver, and therapeutic procedure."
Answered by AI
What other research has there been on the efficacy of combining estradiol and spironolactone?
"As of right now, there are 29 different clinical trials underway that are looking into the efficacy of Daily sublingual estradiol plus spironolactone. Out of those 29 trials, 8 are in Phase 3. Even though the majority of these trials are based in Boston, Massachusetts, there are a total of 293 locations running these studies."
Answered by AI
Are participants still being sought after for this research project?
"Yes, the most recent information available on clinicaltrials.gov reveals that this study is still recruiting patients. The trial was first posted on August 2nd 2021 and was last updated on August 10th 2021. The research is seeking 45 patients from 1 site."
Answered by AI
If an individual is below the age of 35, would they still be able to qualify for this clinical trial?
"This trial only accepts patients aged 18-30. If you are either younger or older than the specified age limit, there are 7 other studies for minors and 21 clinical trials for elderly patients."
Answered by AI
Which types of patients would be the best match for this clinical study?
"This study is looking for 45 transgender individuals aged 18-30. Eligible participants must be female, seen at the Washington University Transgender Center, and meet the readiness criteria for gender-affirming hormone therapy."
Answered by AI
Who else is applying?
What state do they live in?
New Hampshire
Missouri
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Washington University Transgender Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
2
Why did patients apply to this trial?
I have an interest rate n furthering understanding of transgender. I want to make sure im at least getting something. I tried a clinic but was leary.
PatientReceived no prior treatments
I've never felt quite like I should. I've been feeling like a woman was inside trying to escape all my life.
PatientReceived 1 prior treatment
I am very curious and would like to help continue this scientific study and hopefully in the process help others.
PatientReceived no prior treatments
I am so excited to help with any trial that will help the Transgender community better understand the HRT process. I found it difficult to find any information in the past on hormone therapy when I was in transition. I want to help. Please let be part of this program.
PatientReceived no prior treatments
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