NCT06043310

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
68mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Oct 2023Dec 2031

First Submitted

Initial submission to the registry

September 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

October 12, 2023

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

July 4, 2025

Status Verified

June 1, 2025

Enrollment Period

8.1 years

First QC Date

September 12, 2023

Last Update Submit

July 2, 2025

Conditions

EstrogenCardiovascular DiseasesMicrovasculatureOral Contraceptive Use

Keywords

Femaleoral contraceptive

Outcome Measures

Primary Outcomes (2)

  • 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.

    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%).

    0.5 hours

Study Arms (3)

Continuous estrogen/progestin

Females who have had continuous estrogen/progestin treatment for a minimum of 1 year.

Drug: Nω-nitro-L-arginine methyl ester (L-NAME)Drug: AcetylcholineDrug: Sodium Nitroprusside

No Estrogen/progestin

Females who have not had continuous estrogen treatment for a minimum of 5 years.

Drug: Nω-nitro-L-arginine methyl ester (L-NAME)Drug: AcetylcholineDrug: Sodium Nitroprusside

Continuous progestin

Females who have had continuous progestin treatment for a minimum of 1 year.

Drug: Nω-nitro-L-arginine methyl ester (L-NAME)Drug: AcetylcholineDrug: Sodium Nitroprusside

Interventions

Nω-nitro-L-arginine methyl ester (L-NAME)DRUG

L-NAME will be infused locally through microdialysis catheters.

Continuous estrogen/progestinContinuous progestinNo Estrogen/progestin
AcetylcholineDRUG

ACh will be infused locally through microdialysis catheters.

Continuous estrogen/progestinContinuous progestinNo Estrogen/progestin
Sodium NitroprussideDRUG

SNP will be infused locally through microdialysis catheters.

Continuous estrogen/progestinContinuous progestinNo Estrogen/progestin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Hospital

Wauwatosa, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

NG-Nitroarginine Methyl EsterAcetylcholineNitroprusside

Intervention Hierarchy (Ancestors)

ArginineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoBiogenic AminesAminesOrganic ChemicalsFerricyanidesCyanidesAnionsIonsElectrolytesInorganic ChemicalsFerric CompoundsIron CompoundsHydrogen CyanideNitrogen Compounds

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 21, 2023

Study Start

October 12, 2023

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2031

Last Updated

July 4, 2025

Record last verified: 2025-06

Locations

US(1)