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Hormone Therapy

EstroGel® 0.06% for Menopause

Q: Are there any available vacancies for participants in this clinical trial?

Per information from clinicaltrials.gov, patient recruitment is ongoing for this study. It was initially listed on 4/1/2024 and last revised on 3/27/2024.

Q: Is there an age criterion that excludes individuals above 50 years from participating in this medical research study?

Candidates eligible for this clinical investigation must be between the ages of 45 and 65. Additionally, there are separate trials available for individuals under 18 years old (3 trials) as well as those over 65 (27 trials).

Q: What is the upper limit of individuals enrolled in this research endeavor?

Affirmative, the details on clinicaltrials.gov confirm that this study is presently open for participant recruitment. The trial was initially listed on April 1st, 2024 and last revised on March 27th, 2024. A total of 12 participants are sought from a single designated site.

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ -1 through 12 hours for four consecutive days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,644 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

Frequently Asked Questions

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

Are there any available vacancies for participants in this clinical trial?

"Per information from clinicaltrials.gov, patient recruitment is ongoing for this study. It was initially listed on 4/1/2024 and last revised on 3/27/2024."

Answered by AI

Is there an age criterion that excludes individuals above 50 years from participating in this medical research study?

"Candidates eligible for this clinical investigation must be between the ages of 45 and 65. Additionally, there are separate trials available for individuals under 18 years old (3 trials) as well as those over 65 (27 trials)."

Answered by AI

What is the upper limit of individuals enrolled in this research endeavor?

"Affirmative, the details on clinicaltrials.gov confirm that this study is presently open for participant recruitment. The trial was initially listed on April 1st, 2024 and last revised on March 27th, 2024. A total of 12 participants are sought from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Estrogen Hormone Products

Audra Stinchcomb 2024. "Estrogen Hormone Products". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05645406.

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