check_circleStudy Completed

Pharmacokinetics

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
18
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