Gender DysphoriaPhase 4NCT05428215
Comparison of PKs of 17-Beta-Estradiol Via Sublingual Placement Versus Swallowing in Male-to-Female Transgender Patients
A Phase 4 study testing 17beta Estradiol in people with Gender Dysphoria, run by MaineHealth at 1 site in United States.
Trial summary
This crossover study will investigate the pharmacokinetics of oral versus sublingual administration of 17-beta-estradiol in the trans-female population. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gender Dysphoria
- What is being tested?
- 17beta Estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2022to 20 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This crossover study will investigate the pharmacokinetics of oral versus sublingual administration of 17-beta-estradiol in the trans-female population.
- Conditions
- Gender Dysphoria
- Being tested
- 17beta Estradiol
- Keywords
- estradiol, gender-affirming estrogen
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17beta EstradiolDrug
Subjects will take individualized therapeutic dose of 17-beta-estradiol via sublingual and oral administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 17beta Estradiol |
| 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. Receives: Drug: 17beta Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estradiol absorption
Mean area under the curve of estradiol
Measured: Over 24 hours
Secondary outcomes (5)
Peak serum estradiol
With subjects as own controls, compare peak E2 with sublingual vs oral administration
Measured: Peak over 24 hour period
Serum estradiol Nadir
Baseline serum estradiol level after 2 weeks of oral administration versus sublingual administration at same dose
Measured: 24 hours from last estradiol administration
Suppression of Testosterone
Testosterone level after 2 weeks of estradiol administration via oral and sublingual method, respectively
Measured: 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
Measured: 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
Measured: 0 hours from estradiol administration on Study Day 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start29 Dec 2022
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Why it stopped: Inability to adequately recruit participants, need for additional study participants based on preliminary data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Davis, MaineHealth
- Investigators
- Katherine Davis, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428215
- Sponsor's protocol ID
- 1737257
- Status last verified
- Jul 2023
- First submitted
- 11 Jan 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05428215
- Acronym / sponsor ID
- 1737257
- Conditions
- Gender Dysphoria
- Keywords
- estradiol, gender-affirming estrogen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to adequately recruit participants, need for additional study participants based on preliminary data collection
- Enrolment
- 2 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This crossover study will investigate the pharmacokinetics of oral versus sublingual administration of 17-beta-estradiol in the trans-female population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PO then SL | Active comparator | Drug: 17beta EstradiolSubjects 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. |
| SL then PO | Active comparator | Drug: 17beta EstradiolSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17beta EstradiolSubjects will take individualized therapeutic dose of 17-beta-estradiol via sublingual and oral administration | Drug | PO then SL, SL then PO |
Primary outcome
Estradiol absorption
Time frame: Over 24 hours
Mean area under the curve of estradiol
5 secondary outcomes
Peak serum estradiol
Time frame: Peak over 24 hour period
Serum estradiol Nadir
Time frame: 24 hours from last estradiol administration
Suppression of Testosterone
Time frame: 24 hours from last estradiol administration on Study Day 14 and 28
Serum estrone to estradiol ratio
Time frame: Hours from administration of estradiol: 0, 1, 2, 4, 6, and 8 hours
Sex hormone binding globulin
Time frame: 0 hours from estradiol administration on Study Day 14 and 28
Results and safety
The study was stopped early (reason given: Inability to adequately recruit participants, need for additional study participants based on preliminary data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Davis, MD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 17beta Estradiol in people with Gender Dysphoria, run by MaineHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inability to adequately recruit participants, need for additional study participants based on preliminary data collection). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estradiol absorption (time frame: Over 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.