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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000859785

Enrollment

Registered

2022-06-17

Start date

2022-06-17

Completion date

2022-07-08

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Outcome results