check_circleStudy Completed

Postmenopause, Pharmacokinetics

Bayer Identifier:

91032

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to evaluate the effect of Dienogest on Estradiol Valerate pharmacokinetics in postmenopausal women

Trial purpose

Please see attached Study Results Summary below.

Key Participants Requirements

Sex

N/A

Age

N/A

Trial summary

Enrollment Goal
24
Trial Dates
July 2002 - November 2002
Phase
Phase 1
Could I Receive a placebo
N/A
Products
Estradiol Valerate/Dienogest (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
N/A

Primary Outcome

Secondary Outcome

Trial design

Open-label, randomized, two-way crossover study to assess the effect of dienogest on estradiol valerate pharmacokinetics after single oral administration of two different microcrystalline suspensions containing 4 mg estradiol valerate or 4 mg estradiol valerate + 4 mg dienogest in 24 healthy postmenopausal volunteers
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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