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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Estrogen on Human in Vivo Microvascular Function
- ClinicalTrials.gov ID
- NCT06043310
- Acronym / sponsor ID
- PRO40920
- Keywords
- Female, oral contraceptive
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous estrogen/progestin | – | Drug: Nω-nitro-L-arginine methyl ester (L-NAME), Drug: Acetylcholine, Drug: Sodium NitroprussideFemales 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 NitroprussideFemales 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 NitroprussideFemales who have had continuous progestin treatment for a minimum of 1 year. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- Medications that could alter cardiovascular control
- Rash, skin disease, or pigmentation disorders on both forearms
- Anemia
- Kidney Disease
- Known skin allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nω-nitro-L-arginine methyl ester (L-NAME)L-NAME will be infused locally through microdialysis catheters. | Drug | Continuous estrogen/progestin, Continuous progestin, No Estrogen/progestin |
| AcetylcholineACh will be infused locally through microdialysis catheters. | Drug | Continuous estrogen/progestin, Continuous progestin, No Estrogen/progestin |
| Sodium NitroprussideSNP will be infused locally through microdialysis catheters. | Drug | Continuous estrogen/progestin, Continuous progestin, No Estrogen/progestin |
Primary outcome
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.
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%).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Estrogen and Cardiovascular Diseases, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood vessel dilation (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.