Estrogen and Microvascular Function

Medical College of Wisconsin

Status: Not yet enrolling

Conditions: Estrogen; Microvasculature; Oral Contraceptive Use; Cardiovascular Diseases

Treatments: Drug: Nω-nitro-L-arginine methyl ester (L-NAME); Drug: Acetylcholine; Drug: Sodium Nitroprusside

Study type: Observational

Funder types: Other

Identifiers

NCT06043310

PRO40920

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: 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

Trial design

45 participants in 3 patient groups

Continuous estrogen/progestin

Description:

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

Treatment:

Drug: Sodium Nitroprusside

Drug: Acetylcholine

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

No Estrogen/progestin

Description:

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

Treatment:

Drug: Sodium Nitroprusside

Drug: Acetylcholine

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

Continuous progestin

Description:

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

Treatment:

Drug: Sodium Nitroprusside

Drug: Acetylcholine

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