Estrogen and Microvascular Function
The goal of this study is to learn how long-term use of estrogen affects blood vessels in healthy adults who were assigned male at birth. Participants will: * give one blood draw of 5 mL * have a camera placed under the tongue to take pictures of blood vessels * have 2 laser Doppler microdialysis catheters placed on the forearm to monitor blood vessels before and after local drug infusion Researchers will compare blood vessel function of those who take estrogen supplements to those who do not.
Conditions:
🦠 Estrogen 🦠 Cardiovascular Diseases 🦠 Microvasculature
🗓️ Study Start (Actual) 2 June 2023
🗓️ Primary Completion (Estimated) December 2029
✅ Study Completion (Estimated) December 2029
👥 Enrollment (Estimated) 20
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Wauwatosa, Wisconsin, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Adults aged 18-60 years
    • * Identify as assigned male at birth (AMAB) +/- continuous estrogen treatment for a minimum of 1 year.
    • * Blood pressure \<140/ \< 90 mmHg
    • * No more than 1 cardiovascular risk factor

    Exclusion Criteria:

    • * BMI \>35
    • * Medications that could alter cardiovascular control
    • * Rash, skin disease, or pigmentation disorders
    • * Anemia
    • * Kidney Disease
    • * Known skin allergies
    • * Smoking or tobacco use within last 6 months
    • * Coronary Artery Disease
    • * \> 1 cardiovascular risk factor
    • * Hypertension
    • * Diabetes
    • * Hypercholesterolemia
    • * Hyperlipidemia
    • * Bleeding disorders
    • * Use of anti-coagulants
    • * Allergies to study drugs
    • * Erectile dysfunction medication in the past 6 months
    • * Use of topical/non-topical steroids in last 6 months
    • * Internal mouth sores
Ages Eligible for Study: 18 Years to 60 Years (ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 September 2023
  • First Submitted that Met QC Criteria 12 September 2023
  • First Posted 21 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 September 2023
  • Last Update Posted 21 September 2023
  • Last Verified September 2023