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Estrogen and Microvascular Function

Effects of Continuous Estrogen on Human in Vivo Microvascular Function

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06043310
Enrollment
45
Registered
2023-09-21
Start date
2023-10-12
Completion date
2031-12-01
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Estrogen, Microvasculature, Oral Contraceptive Use

Keywords

Female, oral contraceptive

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.

Interventions

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

L-NAME will be infused locally through microdialysis catheters.

DRUGAcetylcholine

ACh will be infused locally through microdialysis catheters.

DRUGSodium Nitroprusside

SNP will be infused locally through microdialysis catheters.

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in blood vessel dilation2 hoursCutaneous vascular conductance in response to acetylcholine, L-NAME, and sodium nitroprusside infusions will be calculated as percentage of cardiovascular conductance.
Change in Perfused Vessel Density0.5 hoursTotal 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%).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026