Estrogen and Microvascular Function

NCT ID: NCT06043310

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-12

Study Completion Date

2031-12-31

Brief Summary

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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

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Conditions

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Estrogen Cardiovascular Diseases Microvasculature Oral Contraceptive Use

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Continuous estrogen/progestin

Females who have had continuous estrogen/progestin treatment for a minimum of 1 year.

Nω-nitro-L-arginine methyl ester (L-NAME)

Intervention Type DRUG

L-NAME will be infused locally through microdialysis catheters.

Acetylcholine

Intervention Type DRUG

ACh will be infused locally through microdialysis catheters.

Sodium Nitroprusside

Intervention Type DRUG

SNP will be infused locally through microdialysis catheters.

No Estrogen/progestin

Females who have not had continuous estrogen treatment for a minimum of 5 years.

Nω-nitro-L-arginine methyl ester (L-NAME)

Intervention Type DRUG

L-NAME will be infused locally through microdialysis catheters.

Acetylcholine

Intervention Type DRUG

ACh will be infused locally through microdialysis catheters.

Sodium Nitroprusside

Intervention Type DRUG

SNP will be infused locally through microdialysis catheters.

Continuous progestin

Females who have had continuous progestin treatment for a minimum of 1 year.

Nω-nitro-L-arginine methyl ester (L-NAME)

Intervention Type DRUG

L-NAME will be infused locally through microdialysis catheters.

Acetylcholine

Intervention Type DRUG

ACh will be infused locally through microdialysis catheters.

Sodium Nitroprusside

Intervention Type DRUG

SNP will be infused locally through microdialysis catheters.

Interventions

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Nω-nitro-L-arginine methyl ester (L-NAME)

L-NAME will be infused locally through microdialysis catheters.

Intervention Type DRUG

Acetylcholine

ACh will be infused locally through microdialysis catheters.

Intervention Type DRUG

Sodium Nitroprusside

SNP will be infused locally through microdialysis catheters.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Julie K. Freed

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Froedtert Hospital

Wauwatosa, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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PRO40920

Identifier Type: -

Identifier Source: org_study_id

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