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OpenTrials
Active, Not Recruiting

NCT Number: NCT06043310

Estrogen and Microvascular Function

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Estrogen Cardiovascular Diseases Microvasculature Oral Contraceptive Use

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Froedtert Hospital

Wauwatosa, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in blood vessel dilation

    Time frame: 2 hours

    Cutaneous vascular conductance in response to acetylcholine, L-NAME, and sodium nitroprusside infusions will be calculated as percentage of cardiovascular conductance.

  2. Change in Perfused Vessel Density

    Time frame: 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%).

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

Effects of Continuous Estrogen on Human in Vivo Microvascular Function

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Sep 21, 2023
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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