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Comparison of PKs of 17-Beta-Estradiol Via Sublingual Placement Versus Swallowing in Male-to-Female Transgender Patients

Primary Purpose

Gender Dysphoria

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

17beta Estradiol

About this trial

This is an interventional treatment trial for Gender Dysphoria focused on measuring estradiol, gender-affirming estrogen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

English speaker
Currently taking 17-beta-estradiol tablet daily via sublingual or oral route on dose therapeutic for gender-affirming therapy; steady dose for at least 4 weeks
Serum estradiol and testosterone levels within target therapeutic range (75-200 pg/mL and <55 ng/dL, respectively)

Exclusion Criteria:

Active or history of deep venous thrombosis/pulmonary embolism
Active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction)
Liver dysfunction
History of breast cancer
History of orchiectomy
Known sensitivity or allergy to any components of the study medication
Taking potent CYP3A4 inhibitors or inducers

Sites / Locations

Maine Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

PO then SL

SL then PO

Arm Description

Subjects will administer 17-beta-estradiol orally (PO) for Study Day 1-14, followed by administration of 17-beta-estradiol sublingually (SL) for Study Day 15-28.

Subjects will administer 17-beta-estradiol sublingually (SL) for Study Day 1-14, followed by administration of 17-beta-estradiol orally (PO) for Study Day 15-28.

Outcomes

Primary Outcome Measures

Estradiol absorption

Mean area under the curve of estradiol

Secondary Outcome Measures

Peak serum estradiol

With subjects as own controls, compare peak E2 with sublingual vs oral administration

Serum estradiol Nadir

Baseline serum estradiol level after 2 weeks of oral administration versus sublingual administration at same dose

Suppression of Testosterone

Testosterone level after 2 weeks of estradiol administration via oral and sublingual method, respectively

Serum estrone to estradiol ratio

E1:E2 ratio over 24 hour period with sublingual vs oral administration

Sex hormone binding globulin

SHBG after 2 weeks of estradiol sublingual vs oral administration

Full Information

NCT ID

NCT05428215

First Posted

January 11, 2022

Last Updated

July 24, 2023

Sponsor

MaineHealth

1. Study Identification

Unique Protocol Identification Number

NCT05428215

Brief Title

Comparison of PKs of 17-Beta-Estradiol Via Sublingual Placement Versus Swallowing in Male-to-Female Transgender Patients

Official Title

Comparison of Pharmacokinetics of 17-Beta-Estradiol Via Oral Administration With Sublingual Placement Versus Oral Administration With Swallowing of 17-Beta-estradiol in Male-to-Female Transgender Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Why Stopped

Inability to adequately recruit participants, need for additional study participants based on preliminary data collection

Study Start Date

December 29, 2022 (Actual)

Primary Completion Date

July 20, 2023 (Actual)

Study Completion Date

July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

MaineHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This crossover study will investigate the pharmacokinetics of oral versus sublingual administration of 17-beta-estradiol in the trans-female population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gender Dysphoria

Keywords

estradiol, gender-affirming estrogen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Model Description

Each subject will take their individualized dose of 17B-estradiol tablet orally for 2 weeks and sublingually for 2 weeks. The subject will then take their same dose of 17B-estradiol via the other means of administration for 2 weeks. The order in which this occurs will be randomized.

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PO then SL

Arm Type

Active Comparator

Arm Description

Subjects will administer 17-beta-estradiol orally (PO) for Study Day 1-14, followed by administration of 17-beta-estradiol sublingually (SL) for Study Day 15-28.

Arm Title

SL then PO

Arm Type

Active Comparator

Arm Description

Subjects will administer 17-beta-estradiol sublingually (SL) for Study Day 1-14, followed by administration of 17-beta-estradiol orally (PO) for Study Day 15-28.

Intervention Type

Drug

Intervention Name(s)

17beta Estradiol

Intervention Description

Subjects will take individualized therapeutic dose of 17-beta-estradiol via sublingual and oral administration

Primary Outcome Measure Information:

Title

Estradiol absorption

Description

Mean area under the curve of estradiol

Time Frame

Over 24 hours

Secondary Outcome Measure Information:

Title

Peak serum estradiol

Description

With subjects as own controls, compare peak E2 with sublingual vs oral administration

Time Frame

Peak over 24 hour period

Title

Serum estradiol Nadir

Description

Baseline serum estradiol level after 2 weeks of oral administration versus sublingual administration at same dose

Time Frame

24 hours from last estradiol administration

Title

Suppression of Testosterone

Description

Testosterone level after 2 weeks of estradiol administration via oral and sublingual method, respectively

Time Frame

24 hours from last estradiol administration on Study Day 14 and 28

Title

Serum estrone to estradiol ratio

Description

E1:E2 ratio over 24 hour period with sublingual vs oral administration

Time Frame

Hours from administration of estradiol: 0, 1, 2, 4, 6, and 8 hours

Title

Sex hormone binding globulin

Description

SHBG after 2 weeks of estradiol sublingual vs oral administration

Time Frame

0 hours from estradiol administration on Study Day 14 and 28

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Transgender male-to-female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: English speaker Currently taking 17-beta-estradiol tablet daily via sublingual or oral route on dose therapeutic for gender-affirming therapy; steady dose for at least 4 weeks Serum estradiol and testosterone levels within target therapeutic range (75-200 pg/mL and <55 ng/dL, respectively) Exclusion Criteria: Active or history of deep venous thrombosis/pulmonary embolism Active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction) Liver dysfunction History of breast cancer History of orchiectomy Known sensitivity or allergy to any components of the study medication Taking potent CYP3A4 inhibitors or inducers

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katherine Davis, MD

Organizational Affiliation

MaineHealth

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maine Medical Center

City

Portland

State/Province

Maine

ZIP/Postal Code

04102

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of PKs of 17-Beta-Estradiol Via Sublingual Placement Versus Swallowing in Male-to-Female Transgender Patients

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