check_circleStudy Completed

Postmenopause, Pharmacokinetics

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