NCT05387577 is a EARLY_PHASE1 clinical trial of Estradiol Tablets in Transgenderism, sponsored by Medical College of Wisconsin.

Who is sponsoring NCT05387577?

NCT05387577 is sponsored by Medical College of Wisconsin.

What drugs are being tested in NCT05387577?

Interventions in NCT05387577: Estradiol Tablets, Transdermal patch, Estradiol Tablets.

What condition does NCT05387577 study?

NCT05387577 studies Transgenderism, Clotting Disorder.

Is NCT05387577 still recruiting?

NCT05387577 is currently terminated. Last updated 21 December 2022.

Last reviewed 2022-12-21 · How we verify

NCT05387577

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Coagulation and Fibrinolysis of Estradiol in Transwomen

Terminated EARLY_PHASE1 Last updated 21 December 2022

What this trial tests

EARLY_PHASE1 trial testing Estradiol Tablets in Transgenderism in 6 participants. Terminated before completion.

Timeline

7 December 2021

Primary endpoint
23 November 2022

23 November 2022

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	7 December 2021
Primary completion	23 November 2022
Estimated completion	23 November 2022
Sites	1 location across United States

Drugs / interventions tested

Estradiol Tablets — full drug profile →
Transdermal patch
Estradiol Tablets — full drug profile →

Conditions studied

Transgenderism — all drugs for Transgenderism →
Clotting Disorder — all drugs for Clotting Disorder →

Sponsor

Medical College of Wisconsin

Who can join

18 and older, male only, with Transgenderism or Clotting Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Participation of transgender and gender diverse persons in cardiovascular clinical trials.
Stamatiou R, Kararigas G. · · 2024 · cited 4× · PMID 39070126 · DOI 10.1016/j.ahjo.2024.100420

Verify or expand the search:

Other trials of Estradiol Tablets

Trials testing the same drug.

NCT04997525 — Estradiol and Progesterone Levels Following Frozen Embryo Transfer · Phase 4 · completed

Other recruiting trials for Transgenderism

Currently open trials in the same condition.

NCT07092527 — Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version · Phase 4 · recruiting
NCT06639776 — Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons · recruiting
NCT06639763 — Erectile Aid Use in Post-phalloplasty and Post-metoidioplasty Transgender Patients · recruiting
NCT06093724 — Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender · NA · recruiting
NCT05883553 — Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients. · NA · recruiting

Other Medical College of Wisconsin trials

Trials by the same sponsor.

NCT07260552 — Rapid Engagement for Solutions to Population and Outcomes Through Networked Dialogue for Coronary Heart Disease · not yet recruiting
NCT06795360 — Weight Changes After Incretin-mimetics · NA · not yet recruiting
NCT07228208 — Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes · NA · not yet recruiting
NCT07298460 — Stimulation-based Therapy to Improve Balance in DCM · Phase 1, PHASE2 · not yet recruiting
NCT07434544 — Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D) · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05387577 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
Last refreshed: 21 December 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05387577.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing