Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000859785
Ethics application status
Approved
Date submitted
13/06/2022
Date registered
17/06/2022
Date last updated
1/03/2023
Date data sharing statement initially provided
17/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Single-Centre Pilot Trial Investigating the absorption of estradiol following a single application to the skin of estradiol coated microparticles
Scientific title
A Single-Centre Pilot Trial Investigating the absorption of estradiol following a single application to the skin of estradiol coated microparticles in healthy post-menopausal women
Secondary ID [1] 307227 0
ESTRENUE Est-01-ST1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopause 326474 0
Condition category
Condition code
Reproductive Health and Childbirth 323746 323746 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single application of estradiol coated microparticles in a topical gel applied directly to the submandibular skin (40 microlites of gel containing 0.4 micrograms of estradiol applied per patient). Administered by investigator to ensure compliance.
Intervention code [1] 323669 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331492 0
Serum estradiol assessed using a venous blood sample.
Timepoint [1] 331492 0
Baseline, 4 hours, 24 hours, 72 hours and 168 hours following the application of the drug
Secondary outcome [1] 410070 0
'Local skin reaction to the intervention assessed using skin photography and graded in accordance with the Local Skin Reaction Grading Scale
Timepoint [1] 410070 0
Baseline, 4 hours, 24 hours, 72 hours and 168 hours following the application of the drug

Eligibility
Key inclusion criteria
Provision of informed written consent
Healthy Post-menopausal women with levels of FSH/LH/E2 (follicle stimulating hormone, luteinizing hormone, oestrogen) according to the definition of “post-menopausal range”, confirmed at screening
WBC greater than or equal to 3.0 x 109/L, granulocytes greater than or equal to 1.5 X 109/L and platelets greater than or equal to 100 x 109/L.
AST or ALT less than or equal to 3 times ULN
eGFR greater than or equal to 60 ml/min/1.73m2
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• BMI of more than or equal to 40
• Known hypersensitivity to oestradiol
• Any medication known to impact on reproductive hormone function.
• Any investigational drugs or participation in any other clinical study for 6 weeks or 5 half life period (in case of an experimental drug, whichever is longer) prior to screening.
• Any reason that the Investigator’s or the sponsor’s opinion may preclude the participant
from inclusion onto study
• Any skin conditions that might be present at screening or baseline that affects the
application area.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/06/2022
Date of last participant enrolment
Anticipated
29/07/2022
Actual
8/07/2022
Date of last data collection
Anticipated
5/08/2022
Actual
19/08/2022
Sample size
Target
3
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 37659 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 311526 0
Commercial sector/Industry
Name [1] 311526 0
Estrenue Pty Ltd
Country [1] 311526 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Estrenue Pty Ltd
Address
Nyroca House
10-20 New Street
North Adelaide
SA, 5006
Country
Australia
Secondary sponsor category [1] 312940 0
None
Name [1] 312940 0
Address [1] 312940 0
Country [1] 312940 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310985 0
Bellberry Committee H: EC00459
Ethics committee address [1] 310985 0
123 Glen Osmond Road
Eastwood SA 5063
Ethics committee country [1] 310985 0
Australia
Date submitted for ethics approval [1] 310985 0
16/03/2022
Approval date [1] 310985 0
19/05/2022
Ethics approval number [1] 310985 0
2022-03-233

Summary
Brief summary
Healthy post menopausal women (n=3)will be recruited into a pilot study to investigate the absorption of estradiol following a single application to the skin of estradiol coated microparticles. A single dose topical application will be applied to the right submandibular skin area (top of the neck just below the jaw line). The primary objective is to assess whether estradiol is absorbed into the circulation of the eligible women
recruited onto study and assess if there are any local reactions. This will be assessed by serum hormone blood levels (over time) and skin photography of the application site.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119590 0
Dr Stephen Birrell
Address 119590 0
Wellend Health
Nyroca House
10-20 New Street
North Adelaide
SA, 5006
Country 119590 0
Australia
Phone 119590 0
+61 419804741
Fax 119590 0
Email 119590 0
[email protected]
Contact person for public queries
Name 119591 0
Stephen Birrell
Address 119591 0
Wellend Health
Nyroca House
10-20 New Street
North Adelaide
SA, 5006
Country 119591 0
Australia
Phone 119591 0
+61 8 70932552
Fax 119591 0
Email 119591 0
[email protected]
Contact person for scientific queries
Name 119592 0
Stephen Birrell
Address 119592 0
Wellend Health
Nyroca House
10-20 New Street
North Adelaide
SA, 5006
Country 119592 0
Australia
Phone 119592 0
+61 8 70932552
Fax 119592 0
Email 119592 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy concerns regarding the small number of participants


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.