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Estrogen

Topical Estrogen 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
Naturally postmenopausal (absence of periods for ≥ 1 year or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy (menopause induced by removal of ovaries)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up -1 through 12 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find out if two products contain the same amount of estrogen.

Who is the study for?
This trial is for postmenopausal women aged 45-65, of any ethnicity, with healthy major organs and no drug abuse history. Participants must have thighs at least 42 cm in circumference to apply the topical estrogen product and be deemed healthy by a medical professional.
What is being tested?
The study is testing whether two different topical estrogen products can deliver equivalent amounts of estradiol, estriol, and estrone to postmenopausal women when applied to their thighs.
What are the potential side effects?
While specific side effects are not listed here, typical side effects from topical estrogen products may include skin irritation at the application site, hormonal changes such as mood swings or hot flashes, and potential systemic effects like headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been in menopause for at least a year or had my ovaries removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~-1 through 12 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and -1 through 12 hours 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)
Group II: Biest creamActive Control1 Intervention
Biest cream (equivalent dose to EstroGel®)

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,488 Total Patients Enrolled
1 Trials studying Menopause
12 Patients Enrolled for Menopause
Audra Stinchcomb, PhDPrincipal InvestigatorUniversity of Maryland, Baltimore
4 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Menopause
12 Patients Enrolled for Menopause
~1 spots leftby Jan 2025
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