Effect of Estradiol Topical Products

What this trial studies

The aim of the present study is to determine if two products can deliver bioequivalent amounts of estrogen (estradiol, estriol, and estrone).

Conditions in scope

• Menopause

Interventions

• topical estrogen product (Drug) — estrogen topical gel or cream

Who can join

Women only · Ages 45 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• Postmenopausal women, who are of any ethnic background, between the age of 45 to 65 years old
• Provide written informed consent before initiation of any of the study procedures
• Able to adhere to the study restrictions and study schedule
• Volunteer has mid thighs of at least 42 cm (16.5 in) in circumference to accommodate the products to be tested at an area of 400 cm2 per thigh
• Volunteer has legs that measure ≥46 cm (18.1 in) in length from the iliac crest to the top of the patella or large enough to accommodate the products to be tested at an area of 400 cm2 per thigh with the subject being comfortable with the template placement
• Volunteer deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination, and medication history
• Negative urine drug screening test (cannabinoids, amphetamines, barbiturates, benzodiazepine, cocaine, methadone, opiates, PCP)
• Have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine transaminase (ALT), and aspartate aminotransferase (AST)

Exclusion criteria

• Smokers/tobacco users (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches, or electronic cigarettes)
• Participation in any ongoing clinical drug trial/study
• Hereditary skin disorders or any skin inflammatory conditions as reported by the volunteer or evident to the MAI
• History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and did not involve the investigative sites
• History as either reported by the volunteer or evident to the investigator of infectious disease or skin infection or of chronic skin disease (e.g., psoriasis, atopic dermatitis)
• Use of medications/alternative treatments/natural products for menopausal symptoms within the last 30 days or during the study
• Use of some chronic prescription medications during the period 0 to 30 days; or over-the-counter medications (e.g. antihistamines, topical corticosteroids, creams, gels, or ointments on your legs) and short term (\<30 days) prescription medications during the period 0-3 days before a procedure day vitamin and herbal supplements not included). Certain types of medications may not exclude volunteers from this study, for example; thyroid medications, allergy medication that is not a steroid, non-steroidal anti-inflammatory drugs (e.g., ibuprofen or naproxen), and lipid/cholesterol lowering drugs.
• Active positive Hepatitis B, C and/or HIV serologies

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: EARLY_PHASE1
• Start date: 2024-06-05
• Primary completion: 2025-03-30
• Last update posted: 2025-05-20
• First posted: 2022-12-09

Sponsor & contact

Lead sponsor: University of Maryland, Baltimore (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• PK (-1 through 12 hours)
  serum concentrations

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.