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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 is a Early Phase 1 study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05387577
The ClinicalTrials.gov registry entry for NCT05387577 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 6 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 2 interventions - of which Transdermal patch is the first listed.
NCT05387577 reports 0 study locations.
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.
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