A Single-Centre Pilot Trial Investigating the absorption of estradiol following a single application to the skin of estradiol coated microparticles

Phase 1

Completed

• Conditions: Menopause; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12622000859785
• Lead Sponsor: Estrenue Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-17
• Study Completion: 2022-08-19
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 3

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum estradiol assessed using a venous blood sample.[Baseline, 4 hours, 24 hours, 72 hours and 168 hours following the application of the drug]

Secondary Outcome Measures

Name	Time	Method
'Local skin reaction to the intervention assessed using skin photography and graded in accordance with the Local Skin Reaction Grading Scale[Baseline, 4 hours, 24 hours, 72 hours and 168 hours following the application of the drug]