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NCT04036500 · ClinicalTrials.gov registry record · Early Phase 1
Transgender Estradiol
A Early Phase 1 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
NCT04036500 is a Early Phase 1 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 11 participants.
The verdict
NCT04036500, a Early Phase 1 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Blogs, word-of-mouth, and small studies from the 1990s in the premature ovarian insufficiency and menopause populations have suggested sublingual or transdermal estradiol may be safer and/or more effective than an oral formulation. Sublingual administration entails holding the estrogen tablet under the tongue and allowing it to dissolve, where its absorption is enhanced by the rich vascularization under the tongue. According to Price et al., sublingual administration results in rapid absorption with significantly higher estradiol levels than does comparable oral dosing. This is likely because sublingual administration will bypass metabolism by the intestines and liver. The transdermal route, which also bypasses first-pass metabolism, is not associated with an increased venous thromboembolic risk nor a significant increase in plasma triglycerides or HDL-cholesterol levels. As such, transdermal estrogen is often preferred over oral formulations, although it is relatively expensive and not accessible to many transgender women. Conversely, sublingual administration of estrogen tablets is widely available and could be a cost-effective alternative to transdermal estrogen. However, there are no well-conducted studies that have evaluated the safety and efficacy of sublingual estrogen therapy in the transgender population. This pilot study will elucidate how estrogen levels in the blood change following sublingual versus oral administration of estradiol in transgender women. This data may be used later to design larger studies on safety and efficacy. Additionally, analyzing a dosage method that patients themselves have tried independently and found effective is also important. This approach incorporates intelligence from the transgender community into our research, creating new knowledge that is supported by data but is founded in existing community insights. Thus, the outcomes of this research have the potential to integrate patient input while also aiding in the developme
Interventions
- DRUG Estradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-09-23 |
| Est. Completion | 2020-07-13 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04036500
The ClinicalTrials.gov registry entry for NCT04036500 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Estradiol is the first listed.
NCT04036500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04036500 about?
NCT04036500 is a clinical study titled "Transgender Estradiol". Blogs, word-of-mouth, and small studies from the 1990s in the premature ovarian insufficiency and menopause populations have suggested sublingual or transdermal estradiol may be safer and/or more effective than an oral formulation. Sublingual administration entails holding the estrogen tablet under ...
What is the current status of trial NCT04036500?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2019-09-23. Estimated completion is 2020-07-13.
What interventions are being tested in trial NCT04036500?
The interventions under investigation include: Estradiol (DRUG).
Who is sponsoring clinical trial NCT04036500?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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