Standard replacement therapy regimen for Cardiovascular Risk Reduction

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic, Rochester, MNCardiovascular Risk ReductionEstradiol Patch - Drug
Eligibility
21 - 45
Female
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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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Baseline, 6 months, and 12 months

Baseline and 12 months
Changes in measurements of whole body and regional fat and fat-free mass
Month 12
Change in Arterial tonometry
Change in Endothelial function
Change in cerebral vascular reactivity
Changes in maximal Voluntary Contraction of the non-dominant arm
Changes to the index of baroreflex sensitivity

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Timed Control Group
1 of 3
Standard replacement therapy regimen
1 of 3
Titrated replacement therapy regimen
1 of 3

Active Control

60 Total Participants · 3 Treatment Groups

Primary Treatment: Standard replacement therapy regimen · No Placebo Group · Phase 2

Timed Control GroupNoIntervention Group · 1 Intervention: Timed Control Group · Intervention Types:
Standard replacement therapy regimen
Drug
ActiveComparator Group · 1 Intervention: Estradiol 100 Micrograms Patch · Intervention Types: Drug
Titrated replacement therapy regimen
Drug
ActiveComparator Group · 1 Intervention: Estradiol Patch · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 months, and 12 months

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,958 Previous Clinical Trials
3,449,391 Total Patients Enrolled
Ekta Kapoor, MBBSPrincipal Investigator - Mayo Clinic
Mayo Clinic

Eligibility Criteria

Age 21 - 45 · Female Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

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)." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.