Study Completed

Contraception

Bayer Identifier:

15060

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2009-018096-13

EU CT Number:

Not Available

Influence of estrogens on DRSP

Trial purpose

Please see attached Study Results Summary below

Key Participants Requirements

Sex

N/A

Age

18 - 35 Years

Trial summary

Enrollment Goal

Trial Dates

June 2010 - March 2011

Phase

Phase 1

Could I Receive a placebo

N/A

Products

Angeliq (E2/DRSP, BAY86-4891)

Accepts Healthy Volunteer

N/A

Where to participate

Status	Institution	Location
Completed	Bayer Pharma AG	Berlin, 13353, Germany
Completed	Dinox GmbH Berlin	Berlin, 10115, Germany

Trial design

A two-center, 4-arm, open-label, randomized study in 80 healthy young women to investigate effects of co-administered estradiol (E2) and ethinylestradiol (EE) on the pharmacokinetics and -dynamics of drospirenone (DRSP) after oral single and multiple doses of three different combinations in comparison to drospirenone alone

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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