EstrogenNCT06043310
Estrogen and Microvascular Function
An observational study of Estrogen and Cardiovascular Diseases, run by Medical College of Wisconsin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Estrogen, Cardiovascular Diseases, Microvasculature
- What is being tested?
- Nω-nitro-L-arginine methyl ester (L-NAME), Acetylcholine and Sodium Nitroprusside
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to Dec 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Continuous Estrogen on Human in Vivo 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.
- Being tested
- Nω-nitro-L-arginine methyl ester (L-NAME), Acetylcholine, Sodium Nitroprusside
- Keywords
- Female, oral contraceptive
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nω-nitro-L-arginine methyl ester (L-NAME)Drug
L-NAME will be infused locally through microdialysis catheters.
AcetylcholineDrug
ACh will be infused locally through microdialysis catheters.
Sodium NitroprussideDrug
SNP will be infused locally through microdialysis catheters.
| Study group | Role | What they receive |
|---|---|---|
| Continuous estrogen/progestin | Females who have had continuous estrogen/progestin treatment for a minimum of 1 year. Receives: Drug: Nω-nitro-L-arginine methyl ester (L-NAME); Drug: Acetylcholine; Drug: Sodium Nitroprusside | |
| No Estrogen/progestin | Females who have not had continuous estrogen treatment for a minimum of 5 years. Receives: Drug: Nω-nitro-L-arginine methyl ester (L-NAME); Drug: Acetylcholine; Drug: Sodium Nitroprusside | |
| Continuous progestin | Females who have had continuous progestin treatment for a minimum of 1 year. Receives: Drug: Nω-nitro-L-arginine methyl ester (L-NAME); Drug: Acetylcholine; Drug: Sodium Nitroprusside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood vessel dilation
Cutaneous vascular conductance in response to acetylcholine, L-NAME, and sodium nitroprusside infusions will be calculated as percentage of cardiovascular conductance.
Measured: 2 hours
Change in Perfused Vessel Density
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%).
Measured: 0.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start12 Oct 2023
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EstrogenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie K. Freed, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043310
- Sponsor's protocol ID
- PRO40920
- Status last verified
- Jun 2026
- First submitted
- 12 Sep 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided