Estrogen and Microvascular Function

Active, not recruiting

• Conditions: Estrogen; Cardiovascular Diseases; Microvasculature; Oral Contraceptive Use
• Interventions: Drug: Nω-nitro-L-arginine methyl ester (L-NAME); Drug: Acetylcholine; Drug: Sodium Nitroprusside

• Registration Number: NCT06043310
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

The goal of this study is to learn how long-term use of estrogen affects blood vessels in healthy adults.

Participants will:

* give one blood draw of 5 mL

* have one Dexa Scan taken to measure adipose and muscle mass

* 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 to those who do not.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-21
• Study Start: 2023-10-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-04
• Primary Completion: 2031-12
• Study Completion: 2031-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

Estrogen/Progestin Group

• Adults aged 18-40 years
• Females with estrogen/progestin treatment for a minimum of 1 year.
• Blood pressure <140/ < 90 mmHg
• No more than 1 cardiovascular risk factor Control Groups
• Adults aged 18-40 years
• Female with no estrogen/progestin treatment for minimum of 5 years.
• Female undergoing progestin only treatment for a minimum of 1 year.
• Blood pressure <140/ < 90 mmHg
• No more than 1 cardiovascular risk factor

Exclusion Criteria

• Medications that could alter cardiovascular control

• Rash, skin disease, or pigmentation disorders on both forearms

• 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

• Use of topical/non-topical steroids in last 6 months

• Internal mouth sores

• Forearms covered with tattoos

• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Continuous progestin	Acetylcholine	Females who have had continuous progestin treatment for a minimum of 1 year.
Continuous progestin	Sodium Nitroprusside	Females who have had continuous progestin treatment for a minimum of 1 year.
Continuous progestin	Nω-nitro-L-arginine methyl ester (L-NAME)	Females who have had continuous progestin treatment for a minimum of 1 year.
No Estrogen/progestin	Acetylcholine	Females who have not had continuous estrogen treatment for a minimum of 5 years.
No Estrogen/progestin	Sodium Nitroprusside	Females who have not had continuous estrogen treatment for a minimum of 5 years.
Continuous estrogen/progestin	Nω-nitro-L-arginine methyl ester (L-NAME)	Females who have had continuous estrogen/progestin treatment for a minimum of 1 year.
Continuous estrogen/progestin	Acetylcholine	Females who have had continuous estrogen/progestin treatment for a minimum of 1 year.
Continuous estrogen/progestin	Sodium Nitroprusside	Females who have had continuous estrogen/progestin treatment for a minimum of 1 year.
No Estrogen/progestin	Nω-nitro-L-arginine methyl ester (L-NAME)	Females who have not had continuous estrogen treatment for a minimum of 5 years.

Primary Outcome Measures

Name	Time	Method
Change in blood vessel dilation	2 hours	Cutaneous vascular conductance in response to acetylcholine, L-NAME, and sodium nitroprusside infusions will be calculated as percentage of cardiovascular conductance.
Change in Perfused Vessel Density	0.5 hours	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%).

Trial Locations

Locations (1)

Froedtert Hospital; 🇺🇸 Wauwatosa, Wisconsin, United States