Study Completed

Contraception

Bayer Identifier:

16245

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2012-001906-28

EU CT Number:

Not Available

Yaz Flex - DDI Ketoconaz and DRSP, in combi w EE and E2

Trial purpose

‘Please see attached Study Results Summary below.’

Key Participants Requirements

Sex

N/A

Age

18 - 45 Years

Trial summary

Enrollment Goal

Trial Dates

September 2012 - April 2013

Phase

Phase 1

Could I Receive a placebo

N/A

Products

YAZ (EE20/DRSP, BAY86-5300)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Berlin, 13353, Germany
Completed		Köln, 51063, Germany

Trial design

Open-label, cross-over, parallel group study to evaluate the effect of repeated oral administration of 200 mg ketoconazole (KTZ) twice daily on the steady-state pharmacokinetics of orally administered drospirenone (DRSP) in combination with ethinylestradiol (EE) or estradiol (E2) after repeated applications of DRSP/EE (containing 3 mg DRSP and 0.02 mg EE) or DRSP/E2 (containing 3 mg DRSP and 1.5 mg E2) in healthy young 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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