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Hormone Therapy

Standard replacement therapy regimen for Cardiovascular Risk Reduction

Phase 2
Waitlist Available
Led By Ekta Kapoor, MBBS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, and 12 months
Awards & highlights

Study Summary

This trial is testing different doses of estrogen to see which is most effective in reducing the risk of heart disease in women who have had their ovaries removed before age 46.

Eligible Conditions
  • Cardiovascular Risk Reduction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Endothelial function
Change in cerebral vascular reactivity
Secondary outcome measures
Change in Arterial tonometry
Changes in maximal Voluntary Contraction of the non-dominant arm
Changes in measurements of whole body and regional fat and fat-free mass
+1 more

Trial Design

3Treatment groups
Active Control
Group I: Standard replacement therapy regimenActive Control1 Intervention
100 mcg transdermal estradiol patch (or equivalent oral dose)
Group II: Titrated replacement therapy regimenActive Control1 Intervention
Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level
Group III: Timed Control GroupActive Control1 Intervention
Healthy age-matched subjects not on hormone therapy

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,737 Total Patients Enrolled
Ekta Kapoor, MBBSPrincipal Investigator - Mayo Clinic
Mayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What overarching goals is this clinical trial attempting to achieve?

"The primary evaluation of this clinical trial, which occurs at Baseline, 6 months, and 12 months is to assess Change in Endothelial function. Additional objectives include gauging Change in Arterial tonometry (Arterial stiffness via high-fidelity pressure waveforms), assessing the index of baroreflex sensitivity (Colder pressor test immersing hand up to wrist in ice water) and measuring whole body and regional fat/fat-free mass (via Dual energy x-ray absorptiometry scans)."

Answered by AI

How many participants are being invited to join this experiment?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this medical research, which was initially posted on March 15th 2019, is actively recruiting individuals for participation. Sixty volunteers need to be enlisted from 1 trial location."

Answered by AI

Are there any openings for participants in this research study at present?

"Indeed, clinicaltrials.gov reveals that this research is actively seeking participants as of October 17th 2022. Initially published on March 15th 2019, the trial requires 60 volunteers from a single medical facility."

Answered by AI

Is the age eligibility for this trial limited to those under 30?

"To be included in this research, individuals must range between 21 and 45 years old. There are 32 studies for those under 18 and 389 trials catered towards seniors above 65."

Answered by AI

Does the FDA currently recognize a Standard replacement therapy regimen?

"Taking into account the lack of prior clinical data demonstrating efficacy, Standard replacement therapy regimen has been assigned a rating of 2 on our safety scale."

Answered by AI

For which clinical indications is the Standard replacement therapy regimen usually prescribed?

"Replacement therapy is the go-to course of action for those with amenorrhea, as well as individuals experiencing hypoestrogenism, vasomotor symptoms related to menopause and breast ailments."

Answered by AI

Who has the potential to qualify for this medical research?

"Participants between the ages of 21 and 45 who are looking to reduce their cardiovascular risk can expect to be recruited for this trial. Approximately 60 people will be chosen in total."

Answered by AI
~8 spots leftby Apr 2025