Trial Outcomes & Findings for Transgender Estradiol (NCT NCT04036500)

NCT ID: NCT04036500

Last Updated: 2025-04-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 11 participants
• Primary outcome timeframe: 8 hours
• Results posted on: 2025-04-11

Participant Flow

Subjects were recruited by flyers in clinic waiting room and in clinic physician referrals. Subjects were initially screened over the phone with the screening criteria (n=17). There were 11 eligible subjects. One subject signed a consent form, but was withdrawn prior to initiation of the study.

After the screening visit in which the pharmacist determined if there was metabolism alternating drugs being taken 10 patients were enrolled.

Participant milestones

Measure	Estradiol 1 mg Oral First, Then Estradiol 1 mg Sublingual Subjects will take estradiol 1 mg orally after time 0 blood draw. They will get 7 blood draws at hours 0,1,2,3,4,6,8. A wash-out period of at least one week will allow for complete clearance of the exogenous oral estradiol before testing the pharmacokinetics of sublingual estradiol on the same ten patients in the same manner. On day 2 of study, subject will take estradiol 1 mg sublingually after time 0 blood draw, supervised by a research team member to ensure proper dissolution. Blood will be drawn at hours 0,1,2,3,4,6,8 as on day 1 of study.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transgender Estradiol

Baseline characteristics by cohort

Measure	Estradiol Oral n=10 Participants Subjects will take estradiol 1 mg orally after time 0 blood draw. They will get 7 blood draws at hours 0,1,2,3,4,6,8. A wash-out period of at least one week will allow for complete clearance of the exogenous oral estradiol before testing the pharmacokinetics of sublingual estradiol on the same ten patients in the same manner. On day 2 of study, subject will take estradiol 1 mg sublingually after time 0 blood draw, supervised by a research team member to ensure proper dissolution. Blood will be drawn at hours 0,1,2,3,4,6,8 as on day 1 of study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex/Gender, Customized Transgender Woman	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 hours

Outcome measures

Measure	Estradiol 1 mg Oral First, Then Estradiol 1 mg Sublingual n=10 Participants Subjects will take estradiol 1 mg orally after time 0 blood draw. They will get 7 blood draws at hours 0,1,2,3,4,6,8. A wash-out period of at least one week will allow for complete clearance of the exogenous oral estradiol before testing the pharmacokinetics of sublingual estradiol on the same ten patients in the same manner. On day 2 of study, subject will take estradiol 1 mg sublingually after time 0 blood draw, supervised by a research team member to ensure proper dissolution. Blood will be drawn at hours 0,1,2,3,4,6,8 as on day 1 of study. Estradiol Tablets: Patients will be given estradiol: 1 mg oral or 1 mg sublingual.
Maximum Serum Concentration of Estradiol Max sublingual serum estradiol	144 pg/mL Standard Deviation 90
Maximum Serum Concentration of Estradiol Max oral serum estradiol	35 pg/mL Standard Deviation 8

PRIMARY outcome

Timeframe: 8 hours

Mean for Area Under the Curve(AUC) for sublingual estradiol.

Outcome measures

Measure

Estradiol 1 mg Oral First, Then Estradiol 1 mg Sublingual n=10 Participants Subjects will take estradiol 1 mg orally after time 0 blood draw. They will get 7 blood draws at hours 0,1,2,3,4,6,8. A wash-out period of at least one week will allow for complete clearance of the exogenous oral estradiol before testing the pharmacokinetics of sublingual estradiol on the same ten patients in the same manner. On day 2 of study, subject will take estradiol 1 mg sublingually after time 0 blood draw, supervised by a research team member to ensure proper dissolution. Blood will be drawn at hours 0,1,2,3,4,6,8 as on day 1 of study. Estradiol Tablets: Patients will be given estradiol: 1 mg oral or 1 mg sublingual.

Area Under the Serum Concentration Versus Time Curve

74.0883 mg*h/L Standard Deviation 17.18

PRIMARY outcome

Timeframe: 8 hours

Outcome measures

Measure

Estradiol 1 mg Oral First, Then Estradiol 1 mg Sublingual n=10 Participants Subjects will take estradiol 1 mg orally after time 0 blood draw. They will get 7 blood draws at hours 0,1,2,3,4,6,8. A wash-out period of at least one week will allow for complete clearance of the exogenous oral estradiol before testing the pharmacokinetics of sublingual estradiol on the same ten patients in the same manner. On day 2 of study, subject will take estradiol 1 mg sublingually after time 0 blood draw, supervised by a research team member to ensure proper dissolution. Blood will be drawn at hours 0,1,2,3,4,6,8 as on day 1 of study. Estradiol Tablets: Patients will be given estradiol: 1 mg oral or 1 mg sublingual.

Oral Clearance of Estradiol

NA mL/hour Standard Deviation NA Data analysis could not be successfully completed with variables provided. Lack of variables made proper analysis impossible. Data was below the level of detection.

SECONDARY outcome

Timeframe: 8 hours

Descriptive statistics, such as mean for ratio of estrone to estradiol

Outcome measures

Measure	Estradiol 1 mg Oral First, Then Estradiol 1 mg Sublingual n=10 Participants Subjects will take estradiol 1 mg orally after time 0 blood draw. They will get 7 blood draws at hours 0,1,2,3,4,6,8. A wash-out period of at least one week will allow for complete clearance of the exogenous oral estradiol before testing the pharmacokinetics of sublingual estradiol on the same ten patients in the same manner. On day 2 of study, subject will take estradiol 1 mg sublingually after time 0 blood draw, supervised by a research team member to ensure proper dissolution. Blood will be drawn at hours 0,1,2,3,4,6,8 as on day 1 of study. Estradiol Tablets: Patients will be given estradiol: 1 mg oral or 1 mg sublingual.
Ratio of Estrone to Estradiol estradiol to estrone ratio, sublingual	1.1 Ratio Standard Deviation 1
Ratio of Estrone to Estradiol estradiol to estrone ratio, oral	0.7 Ratio Standard Deviation 0.4

Adverse Events

Oral Estradiol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sublingual Estradiol

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

Jenna Sarvaideo, DO

Medical College of Wisconsin

Phone: 414-955-7069

Email: jsarvaideo@mcw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place