This study is a Phase I, Randomized, Open-Label, Single Center, Cross-over Study to Investigate the Pharmacokinetics and Safety following a Single Application of Three Different Doses 0.5 gm (0.5 mg estradiol), 0.75 gm (0.75 mg estradiol) and 1.25 gm (1.25 mg estradiol), a Transdermal Estradiol Cream (VML-0203), in comparison to a single dose of EstroGelTM 1.25 gm (1 unit/0.75 mg of estradiol) to healthy post-menopausal women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
20
Each subject will receive the following IMPs in accordance with the randomisation code: * Test IMP: a single-dose of 0.5g, 0.75g and 1.25g VML-0203 cream * Reference IMP: a single-dose of 1.25g EstroGel
Simbec Research Ltd
Merthyr Tydfil, Wales, United Kingdom
RECRUITINGTo compare the bio-availability of estradiol and estrone.
Blood samples will be analysed.
Time frame: 4 weeks
To provide general safety information for VML-0203.
Application site inspections will be assessed.
Time frame: 4 weeks
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