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|ClinicalTrials.gov Identifier: NCT04036500|
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Transgender Persons||Drug: Estradiol Tablets||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sublingual Estradiol Versus Oral Estradiol in Transgender Women|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
Subjects will take estradiol 1 mg orally after time 0 blood draw. They will get 7 blood draws at hours 0,1,2,3,4,6,8. A wash-out period of at least one week will allow for complete clearance of the exogenous oral estradiol before testing the pharmacokinetics of sublingual estradiol on the same ten patients in the same manner. On day 2 of study, subject will take estradiol 1 mg sublingually after time 0 blood draw, supervised by a research team member to ensure proper dissolution. Blood will be drawn at hours 0,1,2,3,4,6,8 as on day 1 of study.
Drug: Estradiol Tablets
Patients will be given estradiol: 1 mg oral or 1 mg sublingual.
- Maximum serum concentration of estradiol [ Time Frame: 8 hours ]
- Half-life of estradiol [ Time Frame: 8 hours ]
- Area under the serum concentration versus time curve [ Time Frame: 8 hours ]
- Oral clearance of estradiol [ Time Frame: 8 hours ]
- Ratio of estrone to estradiol [ Time Frame: 8 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036500
|Contact: Jenna L Investigator, DOemail@example.com|
|Principal Investigator:||Jenna L Investigator, DO||Medical College of Wisconsin|