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Hormone Therapy

Estradiol Products for Menopause

Phase < 1
Recruiting
Led By Audra Stinchcomb, PhD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up -1 through 12 hours for four consecutive days
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find out if two different estradiol products can deliver the same amount of estradiol when taken once or multiple times. "This trial aims to compare two estradiol

Who is the study for?
This trial is for postmenopausal women aged 45-65 with healthy organ function and no drug abuse history. Participants must have legs long enough to apply the gel over a specific area and be comfortable with it. They should not be on any medication that could affect the study outcome.
What is being tested?
The trial is testing two types of estradiol gels: Estrogel and a compounded version, to see if they deliver similar amounts of hormone after being applied once or multiple times.
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include typical estrogen-related reactions such as skin irritation at the application site, hormonal changes, or mood swings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~-1 through 12 hours for four consecutive days
This trial's timeline: 3 weeks for screening, Varies for treatment, and -1 through 12 hours for four consecutive days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PK

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: EstroGel® 0.06%Active Control1 Intervention
EstroGel® 0.06% (1.25 g of gel/dose)
Group II: Compounded estradiol productActive Control1 Intervention
Compounded estradiol product (equivalent to EstroGel®/dose)

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
716 Previous Clinical Trials
381,102 Total Patients Enrolled
1 Trials studying Menopause
4 Patients Enrolled for Menopause
Audra Stinchcomb, PhDPrincipal InvestigatorUniversity of Maryland, Baltimore
4 Previous Clinical Trials
52 Total Patients Enrolled
1 Trials studying Menopause
4 Patients Enrolled for Menopause
~3 spots leftby Mar 2025
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