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NCT05387577 · ClinicalTrials.gov registry record · Early Phase 1
Coagulation and Fibrinolysis of Estradiol in Transwomen
A Early Phase 1 study, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT05387577: Clinical Trial Early Phase 1 study, sponsored by Medical College of Wisconsin.
NCT05387577 is a Early Phase 1 study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05387577, a Early Phase 1 study, was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The specific aim for our study is to measure coagulation system activation and fibrinolysis following transdermal versus sublingual versus oral estradiol versus in transgender women. Hypothesis: Transdermal estradiol will result in less coagulation system activation and no effect on plasminogen activator inhibitor (PAI-1) or tissue-type plasminogen activator (t-PA). Oral estradiol will result in the most coagulation system activation and effect on PAI-1 and t-PA: Oral estradiol \> sublingual estradiol \> transdermal estradiol. A prospective crossover study will include ten subjects given estradiol 1 mg daily and instructed to take it orally, sublingually, or transdermal for 2 months with a 2-week washout period between routes of administration. Labs will be measured 7 times during the study.
Primary Outcome
Comparison of morning fasting labs (fibrinogen, von-Willebrand Factor (vWF) ristocetin cofactor, vWF antigen, D-dimer, protein C activity, free protein S activity, Factors VII, VIII, IX, thrombin generation, plasminogen activator inhibitor (PAI-1), tissue-type plasminogen activator (t-PA) and t-PA activity) in transgender women taking estradiol via different routes of administration. Our hypothesis is that transdermal estradiol will result in less coagulation system activation and no effect on P
Interventions
- DRUG Transdermal patch
- DRUG Estradiol Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-12-07 |
| Est. Completion | 2022-11-23 |
| Phase | Early Phase 1 |
Why NCT05387577 stopped before completion
NCT05387577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Transdermal patch is the first listed.
NCT05387577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05387577 about?
NCT05387577 is a clinical study titled "Coagulation and Fibrinolysis of Estradiol in Transwomen". The specific aim for our study is to measure coagulation system activation and fibrinolysis following transdermal versus sublingual versus oral estradiol versus in transgender women. Hypothesis: Transdermal estradiol will result in less coagulation system activation and no effect on plasminogen act...
What is the current status of trial NCT05387577?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2021-12-07. Estimated completion is 2022-11-23.
What interventions are being tested in trial NCT05387577?
The interventions under investigation include: Transdermal patch (DRUG), Estradiol Tablets (DRUG).
Who is sponsoring clinical trial NCT05387577?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05387577's enrollment target sits among peer trials
6 1845th of 2000 higher than 114 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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