Study Completed

Pharmacokinetics

Bayer Identifier:

91114

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study to evaluate pharmacokinetics of 17β-estradiol using an ultra low dose 17β-estradiol transdermal system SH P00577E (3.25 cm2) in comparison with the reference Climara® SH P00577D (6.5 cm2) transdermal system

Trial purpose

Please see attached Study Results Summary below.

Key Participants Requirements

Sex

N/A

Age

N/A

Trial summary

Enrollment Goal

Trial Dates

April 2002 - June 2002

Phase

Phase 1

Could I Receive a placebo

N/A

Products

Menostar (E2 transdermal, BAY86-5435)

Accepts Healthy Volunteer

N/A

Primary Outcome

Secondary Outcome

Trial design

An open-label, randomized, cross-over study to evaluate the pharmacokinetics of 17β-estradiol and to determine the daily delivery rate of 17β-estradiol from an ultra low dose 17β-estradiol transdermal system SH P00577E (3.25 cm2) in comparison with the reference Climara® SH P00577D (6.5 cm2) transdermal system

Trial Type

Interventional

Intervention Type

N/A

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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