Coagulation & Fibrinolysis of Estradiol in Transwomen

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Subjects will report to our Adult Translational Research Unit for labs at baseline (2 weeks after HRT washout if needed). Both fibrinolysis and testosterone labs have a diurnal variation. Therefore, fasting labs will be drawn at approximately 8 AM. Five subjects will start oral estradiol and 5 will start sublingual estradiol for 8 weeks. Froedtert's Pharmacy Investigational Drug Service will provide the study estradiol. There will be a 2-week washout period between treatment periods. Fasting labs will be drawn at approximately 8 AM prior to Treatment Period 2. The groups will switch therapy. Those that took oral estradiol during Treatment Period 1 will take sublingual estradiol for 8 weeks. Those that took sublingual estradiol during Treatment Period 1 will take oral estradiol for 8 weeks. Finally, all subjects will start the transdermal for 8 weeks for Treatment Period 3. Final set of labs will be drawn at approximately 8 AM 2 weeks after Treatment Period 3. The investigators will call subjects every 2 weeks to assess their adherence to the treatment protocol and remind them of the importance of allowing the tablet to dissolve when taking estradiol sublingually. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05387577
Study type	Interventional
Source	Medical College of Wisconsin
Contact
Status	Terminated
Phase	Early Phase 1
Start date	December 7, 2021
Completion date	November 23, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04977765` - Cardiometabolic Health in Transgender Males
Recruiting	`NCT06074796` - The Determinants of Fertility Preservation in TRANSgender Patients.
Completed	`NCT04454970` - Safe Access for Bladder Entry in Transgender Men Following Penile Reconstruction	N/A
Completed	`NCT04708600` - Effectiveness of Speech Therapy in Trans Women.	N/A
Terminated	`NCT04551144` - Effect of Transgender Therapy on Muscle, Fat and Tissue Receptors
Completed	`NCT04545450` - Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen	Phase 3
Recruiting	`NCT05663892` - Drug-Drug Interaction Study in Trans Women Living With HIV	Phase 4
Completed	`NCT05666102` - Transgender Men's Perspectives on HIV Risk and HIV Prevention Interventions	N/A
Recruiting	`NCT04838249` - Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System
Recruiting	`NCT05883553` - Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.	N/A
Not yet recruiting	`NCT04154358` - Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men	N/A
Recruiting	`NCT04254354` - Transgender Men, Non-binary Persons and Testosterone Treatment BODY IDENTITY CLINIC
Completed	`NCT04969003` - Reducing Transphobia Among Adolescents Through a Brief Video Intervention	N/A
Completed	`NCT06149065` - Factors Associated With the Acne Severity Among Transmen Population: a Cross-sectional Study
Terminated	`NCT04275310` - Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women	N/A
Not yet recruiting	`NCT05415930` - Evaluation of an Adaptative, Multidisciplinary, Reach-out Program, Facilitating Pre Exposition HIV Prophylaxis (PrEP) Prescription and Retention in Care, in a Group of Trans Womens (TW) at High Risk of HIV Infection.
Completed	`NCT04515654` - Supporting Trans Identities and Occupational Justice Through Narrative Informed Theatre: Supporting Trans Identities and Occupational Justice Through Narrative Informed Theatre	N/A
Recruiting	`NCT05761678` - Quality of Life of Transgender People - Implementation and Monitoring of an Online Cohort (e-QoL-Trans)
Not yet recruiting	`NCT06218446` - Transgender Caregivers' and Patients' Representations of Parenthood as Part of a Fertility Preservation Pathway
Recruiting	`NCT05474768` - Expectations and Beliefs of Transgender People Regarding Hormonal Treatment

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Coagulation and Fibrinolysis of Estradiol in Transwomen

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms