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
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
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.