A Single-Centre Pilot Trial Investigating the absorption of estradiol following a single application to the skin of estradiol coated microparticles
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
Estrenue Pty Ltd
3 participants
Jun 17, 2022
Interventional
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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.
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Interventions
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.
Locations(1)
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ACTRN12622000859785