Estrogen for Microvascular Function

SH
JA
Overseen ByJulia A Vogt
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Medical College of Wisconsin
Must be taking: Estrogen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how long-term estrogen use affects blood vessels in healthy adults. Researchers will divide participants into groups based on their past use of hormone treatments like estrogen and progestin, or no use at all. They will compare blood vessel function among these groups using tests such as blood draws and scans. This study is ideal for females aged 18-40 who have been on specific hormone treatments or none for the specified durations and have controlled blood pressure and limited cardiovascular risk factors. As an unphased study, this trial offers participants the chance to contribute to foundational research that may enhance future hormone therapies.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those on medications that could affect heart and blood vessel control. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hormone treatments like estrogen and progestin have been studied for their safety. Using estrogen with progestin can slightly increase the risk of certain health issues, such as blood clots and breast cancer. However, adding progestin reduces the risk of endometrial cancer, which can be a concern for women taking only estrogen.

When using progestin alone, some studies have mentioned side effects like irregular bleeding, but this usually improves over time. Progestin alone can also slightly increase the risk of breast cancer.

Overall, while some risks exist, many women use these treatments safely, especially with a doctor's guidance. It's important to consider these risks and benefits and discuss any concerns with a healthcare provider.12345

Why are researchers excited about this trial?

Researchers are excited about exploring estrogen and progestin treatments because they might offer new insights into improving microvascular function, particularly in females. Unlike current treatments that don't specifically target microvascular health, these hormone therapies could potentially enhance blood vessel function and improve overall cardiovascular health. By examining the effects of continuous estrogen/progestin, continuous progestin, and no hormone treatment, researchers aim to uncover how these hormones influence microvascular systems, paving the way for more targeted and effective therapies in the future.

What evidence suggests that this trial's treatments could be effective for blood vessel function?

This trial will compare different hormone therapy regimens. Research has shown that estrogen and progestin therapy, which participants in the "Continuous estrogen/progestin" arm may receive, can help manage menopause symptoms like hot flashes and night sweats. Studies have found that using estrogen and progestin together can help prevent bone loss, a common issue during menopause. However, this combination might slightly raise the risk of breast cancer.

Participants in the "Continuous progestin" arm will receive progestin alone. Research indicates that progestin might lower the risk of endometrial cancer, which affects the lining of the uterus. Some studies suggest that progestin can improve treatment responses, but there is a higher risk of blood clots with hormone therapies. Considering these benefits and risks is important when evaluating hormone therapy options.46789

Are You a Good Fit for This Trial?

Inclusion Criteria

You must be an AMAB individual who has been receiving estrogen therapy for a minimum period of one year.
Your blood pressure is less than 140/90 mmHg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo procedures to assess blood vessel function, including blood draw, imaging, and catheter placement

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Estrogen

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: No Estrogen/progestinExperimental Treatment3 Interventions
Group II: Continuous progestinExperimental Treatment3 Interventions
Group III: Continuous estrogen/progestinExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Citations

Hormone Replacement Therapy - StatPearls - NCBI Bookshelf

Hormone replacement therapy (HRT) replenishes women with ovarian hormones diminished during the natural menopausal transition to alleviate associated symptoms.

Use of menopausal hormone therapy beyond age 65 years ...

For the use of estrogen and progestogen combo-therapy, both E+ progestin and E+ progesterone were associated with increased risk of breast cancer by 10%-19 ...

Rethinking Menopausal Hormone Therapy: For Whom, ...

Systemic ET represents an effective treatment for VMS and other menopause symptoms, including genitourinary syndrome of menopause (GSM). Oral ...

Effect of continuous and sequential oral estrogen ...

The aim of the present study was to determine whether assignment to continuous estrogen–progestin therapy is more effective in protecting against bone loss.

Hormones for menopause are safe, study finds. ...

We found hormone therapy has low risk of adverse events and is safe for treating bothersome hot flashes, night sweats and other menopausal symptoms.

Risks, Benefits, and Treatment Modalities of Menopausal ...

Results showed an increased risk of 9%-17% of AD in women on either estrogen-progesterone therapy or estrogen therapy alone (OR: 1.17, 95%CI: ...

Menopausal Hormone Therapy and Cancer Risk

Adding a progestin to the estrogen lowers the risk of endometrial cancer back to normal. Because of this, EPT is given to women who still have a ...

Risks and Benefits of Estrogen Plus Progestin in Healthy ...

Conclusions Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy ...

Contemporary menopausal hormone therapy and risk of ...

A higher risk of venous thromboembolism was observed for oral continuous oestrogen-progestin therapy (1.61, 1.35 to 1.92), sequential therapy ...