Study Completed

Acne vulgaris, Contraception

Bayer Identifier:

13854

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2008-004963-20

EU CT Number:

Not Available

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

Trial summary

Enrollment Goal

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

Status	Institution	Location
Completed	SocraTec R&D Clinical Ward	Erfurt, 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

Additional Information

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