Estrogen and Microvascular Function

NCT06043310 — Active not recruiting, 45 participants, Medical College of Wisconsin

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Effects of Continuous Estrogen on Human in Vivo Microvascular Function

Registry	NCT06043310
Status	Active not recruiting
Study type	Observational
Enrollment	45 (Estimated)
Sponsor	Medical College of Wisconsin (Other)
Conditions	Estrogen, Cardiovascular Diseases, Microvasculature, Oral Contraceptive Use
Interventions	Nω-nitro-L-arginine methyl ester (L-NAME), Acetylcholine, Sodium Nitroprusside (Drug)
Dates	start 2023-10-12, primary completion 2031-12-01 (estimated), completion 2031-12-01 (estimated), first posted 2023-09-21, last updated 2026-07-29
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

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

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

+Outcome measures

Primary outcomes

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%).

+Eligibility

Sex: Female, ages: 18 Years to 40 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Froedtert Hospital	Wauwatosa, Wisconsin	United States