- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05645406
Estrogen Hormone Products
April 23, 2024 updated by: Audra Stinchcomb, University of Maryland, Baltimore
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
12
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Audra Stinchcomb, PhD
- Phone Number: 410-706-2646
- Email: astinchc@rx.umaryland.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Recruiting
- General Clinical Research Center (GCRC) at the University of Maryland Medical Center
-
Contact:
- Bianca Reginauld
-
Principal Investigator:
- Audra Stinchcomb, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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)
- 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 90-140 mmHg
- Diastolic blood pressure 60-90 mmHg
- Heart rate 55-100 beats per minute
- Respiration rate 12-20 breaths per minute
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
- 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
- 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 ≥30 kg/m2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: EstroGel® 0.06%
EstroGel® 0.06% (1.25 g of gel/dose)
|
estradiol topical products
Other Names:
|
Active Comparator: Compounded estradiol product
Compounded estradiol product (equivalent to EstroGel®/dose)
|
estradiol topical products
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK
Time Frame: -1 through 12 hours for four consecutive days
|
serum concentrations
|
-1 through 12 hours for four consecutive days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Audra Stinchcomb, PhD, University of Maryland, Baltimore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 15, 2024
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
December 1, 2022
First Submitted That Met QC Criteria
December 1, 2022
First Posted (Actual)
December 9, 2022
Study Record Updates
Last Update Posted (Actual)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00100540
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Study results will be shared via a published manuscript.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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