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Inability to adequately recruit participants, need for additional study participants based on preliminary data collection
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This crossover study will investigate the pharmacokinetics of oral versus sublingual administration of 17-beta-estradiol in the trans-female population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PO then SL | Active Comparator | 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. |
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| SL then PO | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17beta Estradiol | Drug | Subjects will take individualized therapeutic dose of 17-beta-estradiol via sublingual and oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estradiol absorption | Mean area under the curve of estradiol | Over 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Peak serum estradiol | With subjects as own controls, compare peak E2 with sublingual vs oral administration | Peak over 24 hour period |
| Serum estradiol Nadir | Baseline serum estradiol level after 2 weeks of oral administration versus sublingual administration at same dose |
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Inclusion Criteria:
Exclusion Criteria:
Transgender male-to-female
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Davis, MD | MaineHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maine Medical Center | Portland | Maine | 04102 | United States |
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| ID | Term |
|---|---|
| D000068116 | Gender Dysphoria |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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.
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| 24 hours from last estradiol administration |
| Suppression of Testosterone | Testosterone level after 2 weeks of estradiol administration via oral and sublingual method, respectively | 24 hours from last estradiol administration on Study Day 14 and 28 |
| Serum estrone to estradiol ratio | E1:E2 ratio over 24 hour period with sublingual vs oral administration | Hours from administration of estradiol: 0, 1, 2, 4, 6, and 8 hours |
| Sex hormone binding globulin | SHBG after 2 weeks of estradiol sublingual vs oral administration | 0 hours from estradiol administration on Study Day 14 and 28 |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |