MenopauseEarly Phase 1NCT05645406
Estrogen Hormone Products
A Early Phase 1 study testing Divigel 0.1% Topical Gel and Compounded estradiol product in people with Menopause, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose is to determine if the two estradiol products can deliver similar amounts of estradiol after single and multiple dosing. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Divigel 0.1% Topical Gel and Compounded estradiol product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2024to 15 Jun 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
- Systolic blood pressure 90-165 mmHg
- Diastolic blood pressure 60-100 mmHg
- Heart rate 55-100 beats per minute
- Respiration rate 12-20 breaths per minute
Who cannot join
- 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.
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- 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
- Breast cancer or history of breast cancer
- Undiagnosed abnormal genital bleeding
- Estrogen-dependent neoplasia (tumor)
- Active arterial thromboembolic disease (example, stroke or heart attack), or a history of these conditions
- Active DVT (blood clots in deep vein such as lower leg, thigh, pelvis or can occur in arm), PE (blood clot in blood vessel; often leg), or history of these conditions
- Hepatic (liver) impairment or disease
- A history of Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders (tendency to form blood clots)
- At application site, volunteer has an obvious difference in skin color between thighs, presence of a skin condition, excessive hair, sunburn, raised moles and scars, open sores, scar tissue, tattoo, or coloration that would interfere with placement of products, skin assessment, or reactions to estradiol
- BMI ≥32 kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center (GCRC) at the University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Evaluating Quality Performance of Extemporaneously Compounded Estrogen Hormone Products
The purpose is to determine if the two estradiol products can deliver similar amounts of estradiol after single and multiple dosing.
- Conditions
- Menopause
- Being tested
- Divigel 0.1% Topical Gel, Compounded estradiol product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divigel 0.1% Topical GelDrug
Also called estradiol gel
estradiol topical products
Compounded estradiol productDrug
Also called estradiol topical product
estradiol topical products
| Study group | Role | What they receive |
|---|---|---|
| Divigel 0.1% | Active comparator | Divigel 0.1% (1.25 g of gel/dose) Receives: Drug: Divigel 0.1% Topical Gel |
| Compounded estradiol product | Active comparator | Compounded estradiol product (equivalent to Divigel/dose) Receives: Drug: Compounded estradiol product |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK
serum concentrations
Measured: -1 through 12 hours for four consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start14 May 2024
- Primary completion12 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audra Stinchcomb, University of Maryland, Baltimore
- Investigators
- Audra Stinchcomb, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645406
- Sponsor's protocol ID
- HP-00100540
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2022
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Study results will be shared via a published manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Quality Performance of Extemporaneously Compounded Estrogen Hormone Products
- ClinicalTrials.gov ID
- NCT05645406
- Acronym / sponsor ID
- HP-00100540
- Conditions
- Menopause
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to determine if the two estradiol products can deliver similar amounts of estradiol after single and multiple dosing.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Divigel 0.1% | Active comparator | Drug: Divigel 0.1% Topical GelDivigel 0.1% (1.25 g of gel/dose) |
| Compounded estradiol product | Active comparator | Drug: Compounded estradiol productCompounded estradiol product (equivalent to Divigel/dose) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Divigel 0.1% Topical GelAlso: estradiol gelestradiol topical products | Drug | Divigel 0.1% |
| Compounded estradiol productAlso: estradiol topical productestradiol topical products | Drug | Compounded estradiol product |
Primary outcome
PK
Time frame: -1 through 12 hours for four consecutive days
serum concentrations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No. Study results will be shared via a published manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audra Stinchcomb, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Divigel 0.1% Topical Gel and Compounded estradiol product in people with Menopause, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK (time frame: -1 through 12 hours for four consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.