Estrogen and Microvascular Function

Cardiovascular Diseases Clinical Trial

Official title:

Sex-specific Effects of Continuous Estrogen on Human in Vivo Microvascular Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043310
• Other study ID #: PRO40920
• Status: Recruiting
• Start date: June 2, 2023
• Est. completion date: December 2029

Study information

• Verified date: September 2023
• Source: Medical College of Wisconsin
• Contact: Shona Hang
• Phone: 414-955-2348
• Email: shang[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Estrogen

Intervention

Drug:
• N?-nitro-L-arginine methyl ester (L-NAME)
L-NAME will be infused locally through microdialysis catheters.
• Acetylcholine
ACh will be infused locally through microdialysis catheters.
• Sodium Nitroprusside
SNP will be infused locally through microdialysis catheters.

Locations

Country	Name	City	State
United States	Froedtert Hospital	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood vessel dilation	Cutaneous vascular conductance in response to acetylcholine, L-NAME, and sodium nitroprusside infusions will be calculated as percentage of cardiovascular conductance.	2 hours
Primary	Change in Perfused Vessel Density	Total vessel density (TVD) will be calculated using the DeBacker Score manual analysis on all images that have a minimum microcirculation image quality score (MIQS) of 10. Perfused vessel density (PVD) will be calculated by multiplying total vessel density (TVD) x proportion of perfused vessels (PPV%).	0.5 hours