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A phase I study to compare the steady-state pharmacokinetics of estradiol following application to the abdomen of an Estradiol Metered-Dose Transdermal Spray (MDTS) and Estraderm 50 patches in healthy postmenopausal women, as hormone replacement therapy.

A phase I study to compare the steady-state pharmacokinetics of estradiol following application to the abdomen of an Estradiol Metered-Dose Transdermal Spray (MDTS) and Estraderm 50 patches in healthy postmenopausal women, as hormone replacement therapy.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000521628
Enrollment
18
Registered
2005-09-26
Start date
2002-03-08
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 Metered-Dose Transdermal Spray (MDTS) and Estraderm 50 patches up to 7 days.

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

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Healthy post-menopausal women

Exclusion criteria

No exclusion criteria

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026