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A Pharmacokinetic Phase I Study to Assess the Effect of Different Application Sites and Formulations, on the Relative Bioavailability and Pharmacokinetics of Estradiol in postmenopausal women from a Metered Dose Transdermal System (MDTS) as hormone replacement therapy.

A Pharmacokinetic Phase I Study to Assess the Effect of Different Application Sites and Formulations, on the Relative Bioavailability and Pharmacokinetics of Estradiol in postmenopausal women from a Metered Dose Transdermal System (MDTS) as hormone replacement therapy.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000520639
Enrollment
12
Registered
2005-09-26
Start date
2002-07-15
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Interventions

Estradiol MDTS, 7-days, 3-period crossover

Sponsors

FemPharm Pty Ltd and/or Acrux DDS Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Age
-2147483648 Years to -2147483648 Years
Healthy volunteers
Yes

Inclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026