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Estrogen cream showdown: do custom formulas match up?

NCT ID NCT05645406

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether two specially made estrogen creams deliver similar amounts of the hormone into the blood. Eight postmenopausal women aged 45 to 65 used both creams, and researchers measured hormone levels after single and repeated use. The goal was to check quality, not to treat any condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

8 people

The number who actually took part.

Started

May 2024

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 65 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Postmenopausal women, who are of any ethnic background, between the age of 45 to 65 years old 2. Provide written informed consent before initiation of any of the study procedures 3. Able to adhere to the study restrictions and study schedule 4. 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 5. 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 6. Volunteer deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination, and medication history 7. Negative urine drug screening test (cannabinoids, amphetamines, barbiturates, benzodiazepine, cocaine, methadone, opiates, PCP) 8. 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) 9. Have normal screening laboratories for urine protein and urine glucose 10. Naturally postmenopausal (absence of periods for ≥ 1 year or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy (menopause induced by removal of ovaries) 11. 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 12. Agrees not to donate blood to a blood bank throughout participation in the study and for at least three months after last procedure day 13. 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) 14. 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 Exclusion Criteria: 1. 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) 2. Participation in any ongoing clinical drug trial/study 3. Hereditary skin disorders or any skin inflammatory conditions as reported by the volunteer or evident to the MAI 4. 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 5. 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) 6. Use of medications/alternative treatments/natural products for menopausal symptoms within the last 30 days or during the study. 7. 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. 8. Active positive Hepatitis B, C and/or HIV serologies 9. Positive urine drug screening test 10. Use of estrogen-containing implants, topical, or oral products 11. Donation or loss of greater than one pint of blood within 60 days of entry to the study 12. Any prior allergies to estradiol and its products or other ingredients in the applied gel or cream 13. 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 14. 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 15. History of diabetes 16. Breast cancer or history of breast cancer 17. Undiagnosed abnormal genital bleeding 18. Estrogen-dependent neoplasia (tumor) 19. Active arterial thromboembolic disease (example, stroke or heart attack), or a history of these conditions 20. 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 21. Hepatic (liver) impairment or disease 22. A history of Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders (tendency to form blood clots) 23. 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 24. BMI ≥32 kg/m2

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Baltimore, Maryland, 21201, United States

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