CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 11 enrolled
Drug / intervention
Estradioldrug
Likely dose
Estradiol 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04036500
NCT04036500Early Ph 1Completed

Sublingual Estradiol Versus Oral Estradiol in Transgender Women

Medical College of Wisconsin·interventional·Posted Jul 29, 2019·Updated Apr 11, 2025

In Brief

A Early Phase 1 clinical trial evaluating Estradiol for Transgender Persons. Completed, enrolled 11 participants across 1 site.

Detailed 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 development of safety recommendations, with the goal of better caring for our transgender patients. Primary aim. To establish the pharmacokinetics of sublingual estradiol versus oral estradiol in transgender women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
2020202120222023202420252026
First PostedJul 29, 2019
Enrollment StartSep 23, 2019
Primary CompletionJul 13, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.9 years ago

Interventions

Estradioldrug

Patients will be given estradiol: 1 mg oral and 1 mg sublingual.