Trial Outcomes & Findings for Transgender Estradiol Affirming Therapy (NCT NCT05010707)
NCT ID: NCT05010707
Last Updated: 2024-11-26
Results Overview
Degree of testosterone suppression by measuring total testosterone level in transgender female patients undergoing hormonal affirming therapy, clinical testosterone level in pg/mL
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Change from baseline total testosterone level at 1 and 6 months
Results posted on
2024-11-26
Participant Flow
Participant milestones
| Measure |
Transdermal Estradiol Plus Spironolactone
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.
Transdermal patch: Participants will be prescribed the medication and dosed based on their hormonal profile. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
|
Daily Sublingual Estradiol Plus Spironolactone
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.
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
Daily Sublingual Tablet: Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as once daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels.
|
Twice Daily Sublingual Estradiol Plus Spironolactone
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.
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
BID Sublingual Tablet: Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as twice daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
14
|
|
Overall Study
COMPLETED
|
11
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transgender Estradiol Affirming Therapy
Baseline characteristics by cohort
| Measure |
Transdermal Estradiol Plus Spironolactone
n=12 Participants
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.
Transdermal patch: Participants will be prescribed the medication and dosed based on their hormonal profile. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
|
Daily Sublingual Estradiol Plus Spironolactone
n=13 Participants
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.
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
Daily Sublingual Tablet: Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as once daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels.
|
Twice Daily Sublingual Estradiol Plus Spironolactone
n=14 Participants
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.
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
BID Sublingual Tablet: Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as twice daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
25.3 years
n=5 Participants
|
25.0 years
n=7 Participants
|
21.5 years
n=5 Participants
|
25.3 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Weight
|
75.6 Kg
STANDARD_DEVIATION 17.2 • n=5 Participants
|
82.1 Kg
STANDARD_DEVIATION 20.9 • n=7 Participants
|
74.0 Kg
STANDARD_DEVIATION 13.0 • n=5 Participants
|
77.3 Kg
STANDARD_DEVIATION 17.2 • n=4 Participants
|
|
BMI
|
25.2 kg/m^2
STANDARD_DEVIATION 5.9 • n=5 Participants
|
26.2 kg/m^2
STANDARD_DEVIATION 7.2 • n=7 Participants
|
23.9 kg/m^2
STANDARD_DEVIATION 5.0 • n=5 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 6.0 • n=4 Participants
|
|
Systolic blood pressure
|
132.8 mmHg
STANDARD_DEVIATION 12.6 • n=5 Participants
|
140.8 mmHg
STANDARD_DEVIATION 21.7 • n=7 Participants
|
128.3 mmHg
STANDARD_DEVIATION 16.9 • n=5 Participants
|
134.0 mmHg
STANDARD_DEVIATION 18.0 • n=4 Participants
|
|
Diastolic blood pressure
|
87.9 mmHg
STANDARD_DEVIATION 6.7 • n=5 Participants
|
87.5 mmHg
STANDARD_DEVIATION 9.7 • n=7 Participants
|
82.1 mmHg
STANDARD_DEVIATION 10.4 • n=5 Participants
|
86.0 mmHg
STANDARD_DEVIATION 9.0 • n=4 Participants
|
|
Height
|
173.5 cm
STANDARD_DEVIATION 6.5 • n=5 Participants
|
177.6 cm
STANDARD_DEVIATION 9.9 • n=7 Participants
|
176.9 cm
STANDARD_DEVIATION 8.4 • n=5 Participants
|
175.9 cm
STANDARD_DEVIATION 8.4 • n=4 Participants
|
|
Waist circumference
|
34.8 inch
STANDARD_DEVIATION 7.0 • n=5 Participants
|
36 inch
STANDARD_DEVIATION 7.2 • n=7 Participants
|
33.9 inch
STANDARD_DEVIATION 5.2 • n=5 Participants
|
34.9 inch
STANDARD_DEVIATION 6.3 • n=4 Participants
|
|
Lifestyle
Alcohol use
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Lifestyle
Vaping
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Estradiol
|
27.1 pg/mL
STANDARD_DEVIATION 15.5 • n=5 Participants
|
25.8 pg/mL
STANDARD_DEVIATION 10.8 • n=7 Participants
|
23.4 pg/mL
STANDARD_DEVIATION 13.5 • n=5 Participants
|
25.3 pg/mL
STANDARD_DEVIATION 13.0 • n=4 Participants
|
|
Estrone
|
37.2 pg/mL
STANDARD_DEVIATION 20.7 • n=5 Participants
|
27.7 pg/mL
STANDARD_DEVIATION 20.9 • n=7 Participants
|
26.7 pg/mL
STANDARD_DEVIATION 14.0 • n=5 Participants
|
30.2 pg/mL
STANDARD_DEVIATION 18.7 • n=4 Participants
|
|
Total testosterone
|
498.1 ng/dL
STANDARD_DEVIATION 160.6 • n=5 Participants
|
481.3 ng/dL
STANDARD_DEVIATION 230.2 • n=7 Participants
|
505.3 ng/dL
STANDARD_DEVIATION 206.5 • n=5 Participants
|
495.0 ng/dL
STANDARD_DEVIATION 198.1 • n=4 Participants
|
|
Sodium
|
140.3 mmol/L
STANDARD_DEVIATION 2.1 • n=5 Participants
|
140.4 mmol/L
STANDARD_DEVIATION 1.4 • n=7 Participants
|
139.1 mmol/L
STANDARD_DEVIATION 1.6 • n=5 Participants
|
139.9 mmol/L
STANDARD_DEVIATION 1.8 • n=4 Participants
|
|
Potassium
|
4.0 mmol/L
STANDARD_DEVIATION 0.4 • n=5 Participants
|
4.0 mmol/L
STANDARD_DEVIATION 0.3 • n=7 Participants
|
4.2 mmol/L
STANDARD_DEVIATION 0.5 • n=5 Participants
|
4.1 mmol/L
STANDARD_DEVIATION 0.4 • n=4 Participants
|
|
Chloride
|
103.0 mmol/L
STANDARD_DEVIATION 1.9 • n=5 Participants
|
102.9 mmol/L
STANDARD_DEVIATION 2.4 • n=7 Participants
|
101.6 mmol/L
STANDARD_DEVIATION 2.0 • n=5 Participants
|
102.4 mmol/L
STANDARD_DEVIATION 2.2 • n=4 Participants
|
|
Bicarbonate
|
24.2 mmol/L
STANDARD_DEVIATION 3.1 • n=5 Participants
|
26.0 mmol/L
STANDARD_DEVIATION 2.9 • n=7 Participants
|
25.1 mmol/L
STANDARD_DEVIATION 3.5 • n=5 Participants
|
25.1 mmol/L
STANDARD_DEVIATION 3.2 • n=4 Participants
|
|
Blood urea nitrogen
|
14.3 mg/dL
STANDARD_DEVIATION 3.7 • n=5 Participants
|
12.5 mg/dL
STANDARD_DEVIATION 3.2 • n=7 Participants
|
14.1 mg/dL
STANDARD_DEVIATION 5.5 • n=5 Participants
|
13.6 mg/dL
STANDARD_DEVIATION 4.3 • n=4 Participants
|
|
Creatinine
|
1.0 mg/dL
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.1 • n=7 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.2 • n=4 Participants
|
|
Calcium
|
9.7 mg/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
9.6 mg/dL
STANDARD_DEVIATION 0.3 • n=7 Participants
|
9.8 mg/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
9.7 mg/dL
STANDARD_DEVIATION 0.3 • n=4 Participants
|
|
Total bilirubin
|
0.5 mg/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
0.5 mg/dL
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.5 mg/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
0.5 mg/dL
STANDARD_DEVIATION 0.3 • n=4 Participants
|
|
Plasma protein
|
7.8 g/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
7.7 g/dL
STANDARD_DEVIATION 0.4 • n=7 Participants
|
7.8 g/dL
STANDARD_DEVIATION 0.7 • n=5 Participants
|
7.7 g/dL
STANDARD_DEVIATION 0.5 • n=4 Participants
|
|
Albumin
|
4.9 g/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
4.9 g/dL
STANDARD_DEVIATION 0.3 • n=7 Participants
|
4.9 g/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
4.9 g/dL
STANDARD_DEVIATION 0.3 • n=4 Participants
|
|
Alkaline phosphatase
|
82.3 U/L
STANDARD_DEVIATION 22.1 • n=5 Participants
|
75.9 U/L
STANDARD_DEVIATION 24.0 • n=7 Participants
|
77.6 U/L
STANDARD_DEVIATION 17.0 • n=5 Participants
|
78.4 U/L
STANDARD_DEVIATION 20.6 • n=4 Participants
|
|
AST
|
25.2 U/L
STANDARD_DEVIATION 6.0 • n=5 Participants
|
23.0 U/L
STANDARD_DEVIATION 6.4 • n=7 Participants
|
22.2 U/L
STANDARD_DEVIATION 6.6 • n=5 Participants
|
23.3 U/L
STANDARD_DEVIATION 6.3 • n=4 Participants
|
|
ALT
|
30.3 U/L
STANDARD_DEVIATION 16.2 • n=5 Participants
|
23.2 U/L
STANDARD_DEVIATION 9.7 • n=7 Participants
|
24.1 U/L
STANDARD_DEVIATION 14.8 • n=5 Participants
|
25.6 U/L
STANDARD_DEVIATION 13.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline total testosterone level at 1 and 6 monthsPopulation: Baseline Measures
Degree of testosterone suppression by measuring total testosterone level in transgender female patients undergoing hormonal affirming therapy, clinical testosterone level in pg/mL
Outcome measures
| Measure |
Transdermal Estradiol Plus Spironolactone
n=11 Participants
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.
Transdermal patch: Participants will be prescribed the medication and dosed based on their hormonal profile. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
|
Daily Sublingual Estradiol Plus Spironolactone
n=13 Participants
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.
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
Daily Sublingual Tablet: Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as once daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
|
Twice Daily Sublingual Estradiol Plus Spironolactone
n=14 Participants
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.
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
BID Sublingual Tablet: Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as twice daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
|
|---|---|---|---|
|
Total Testosterone Level in Transgender Female Patients
Baseline
|
498.6 pg/mL
Standard Error 46.2
|
481.3 pg/mL
Standard Error 61.3
|
505.3 pg/mL
Standard Error 53.2
|
|
Total Testosterone Level in Transgender Female Patients
1 Month
|
62.7 pg/mL
Standard Error 13.7
|
278.5 pg/mL
Standard Error 54.8
|
313.8 pg/mL
Standard Error 69.7
|
|
Total Testosterone Level in Transgender Female Patients
6 Month
|
29.4 pg/mL
Standard Error 7.4
|
108.1 pg/mL
Standard Error 46.5
|
124.7 pg/mL
Standard Error 72.5
|
PRIMARY outcome
Timeframe: Change from baseline estradiol level at 1 and 6 monthsDegree of testosterone suppression by measuring estradiol level in transgender female patients affirming hormone therapy
Outcome measures
| Measure |
Transdermal Estradiol Plus Spironolactone
n=11 Participants
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.
Transdermal patch: Participants will be prescribed the medication and dosed based on their hormonal profile. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
|
Daily Sublingual Estradiol Plus Spironolactone
n=13 Participants
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.
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
Daily Sublingual Tablet: Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as once daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
|
Twice Daily Sublingual Estradiol Plus Spironolactone
n=14 Participants
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.
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
BID Sublingual Tablet: Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as twice daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
|
|---|---|---|---|
|
Estradiol Level in Transgender Female Patients
baseline
|
28.3 pg/mL
Standard Error 4.4
|
25.8 pg/mL
Standard Error 2.9
|
23.4 pg/mL
Standard Error 3.5
|
|
Estradiol Level in Transgender Female Patients
1 Month
|
56.8 pg/mL
Standard Error 9.4
|
52.6 pg/mL
Standard Error 9.6
|
55.2 pg/mL
Standard Error 5.2
|
|
Estradiol Level in Transgender Female Patients
6 Months
|
74.0 pg/mL
Standard Error 15.6
|
95.3 pg/mL
Standard Error 10.5
|
79.4 pg/mL
Standard Error 11.6
|
PRIMARY outcome
Timeframe: Change from baseline estrone level at 1, and 6 monthsDegree of testosterone suppression by measuring estrone level in transgender female patients affirming hormone therapy
Outcome measures
| Measure |
Transdermal Estradiol Plus Spironolactone
n=11 Participants
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.
Transdermal patch: Participants will be prescribed the medication and dosed based on their hormonal profile. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
|
Daily Sublingual Estradiol Plus Spironolactone
n=13 Participants
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.
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
Daily Sublingual Tablet: Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as once daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
|
Twice Daily Sublingual Estradiol Plus Spironolactone
n=14 Participants
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.
Pro-thrombotic markers: Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
Metabolic markers: Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
Hormone Profile: Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
BID Sublingual Tablet: Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as twice daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
|
|---|---|---|---|
|
Estrone Level in Transgender Female Patients
1 Month
|
41.0 pg/ml
Standard Error 5.2
|
302 pg/ml
Standard Error 76.1
|
240.1 pg/ml
Standard Error 36.4
|
|
Estrone Level in Transgender Female Patients
baseline
|
33.5 pg/ml
Standard Error 6.8
|
27.7 pg/ml
Standard Error 5.7
|
26.7 pg/ml
Standard Error 3.7
|
|
Estrone Level in Transgender Female Patients
6 Months
|
57.3 pg/ml
Standard Error 7.7
|
635.7 pg/ml
Standard Error 81.3
|
532.9 pg/ml
Standard Error 124.6
|
Adverse Events
Transdermal Estradiol Plus Spironolactone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Daily Sublingual Estradiol Plus Spironolactone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Twice Daily Sublingual Estradiol Plus Spironolactone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas Baranski, MD, PhD
Washington University in St. Louis, School of Medicine
Phone: 314-747-3997
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place