Estrogen Hormone Products

NCT05645406 | Completed Early Phase 1 FDA Drug

• 1 other identifier: HP-00100540
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to determine if the two estradiol products can deliver similar amounts of estradiol after single and multiple dosing.

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

• PK

  serum concentrations

  -1 through 12 hours for four consecutive days

Study Arms (2)

Divigel 0.1%

ACTIVE COMPARATOR

Divigel 0.1% (1.25 g of gel/dose)

Drug: Divigel 0.1% Topical Gel

Compounded estradiol product

ACTIVE COMPARATOR

Compounded estradiol product (equivalent to Divigel/dose)

Drug: Compounded estradiol product

Interventions

Divigel 0.1% Topical Gel DRUG

estradiol topical products

Also known as: estradiol gel

Divigel 0.1%

Compounded estradiol product DRUG

estradiol topical products

Also known as: estradiol topical product

Compounded estradiol product

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Have normal screening laboratories for urine protein and urine glucose
• Naturally postmenopausal (absence of periods for ≥ 1 year or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy (menopause induced by removal of ovaries)
• Agree not to participate in another clinical trial/study or to participate in an investigational drug study for at least one month after the last procedure day
• Agrees not to donate blood to a blood bank throughout participation in the study and for at least three months after last procedure day
• Have a normal ECG; must not have the following to be acceptable: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block. (sinus rhythm is between 55-100 beats per minute)
• Have normal vital signs:
• Temperature 35-37.9°C (95-100.3°F)

You may not qualify if:

• 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
• Positive urine drug screening test
• Use of estrogen-containing implants, topical, or oral products
• Donation or loss of greater than one pint of blood within 60 days of entry to the study
• Any prior allergies to estradiol and its products or other ingredients in the applied gel or cream
• Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within one month before enrollment in this study or expects to receive an experimental agent during the study
• Any condition that would, in the opinion of the Medically Accountable Investigator (MAI), place the volunteer at an unacceptable risk of injury or render the volunteer unable to meet the requirements of the protocol
• History of diabetes

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

General Clinical Research Center (GCRC) at the University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Estradiol; Gels

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Audra Stinchcomb, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: May 14, 2024
• Primary Completion: June 12, 2025
• Study Completion: June 15, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)