check_circleStudy Completed

Acne vulgaris, Contraception

DC 00066,Phase I Bioavailability, Bioequivalence Study

Trial purpose

Please see attached Study Results Summary below

Key Participants Requirements

Sex

N/A

Age

55 - 75 Years
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Trial summary

Enrollment Goal
36
Trial Dates
November 2008 - December 2008
Phase
Phase 1
Could I Receive a placebo
N/A
Products
Valette (Dienogest/EE30, BAY86-5038)
Accepts Healthy Volunteer
N/A

Where to participate

StatusInstitutionLocation
Completed
SocraTec R&D Clinical WardErfurt, 99084, Germany

Trial design

Characterization of relative bioavailability and assessment of bioequivalence of a gelatine-free in comparison to a gelatine-containing coated tablet formulation containing 2 mg dienogest and 0.03 mg ethinylestradiol in a single dose, two way crossover, open, randomized study under fasting conditions in postmenopausal women
Trial Type
Interventional
Intervention Type
N/A
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A