check_circleStudy Completed

Contraception

Bayer Identifier:

13185

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2010-018725-20

EU CT Number:

Not Available
FC Patch low: DDI midazolam

Trial purpose

Please see attached Study Results Summary below

Key Participants Requirements

Sex

N/A

Age

18 - 45 Years
  • -

  • -

Trial summary

Enrollment Goal
32
Trial Dates
April 2010 - September 2010
Phase
Phase 1
Could I Receive a placebo
N/A
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
N/A

Where to participate

StatusInstitutionLocation
Completed
Bayer Pharma AGBerlin, 13353, Germany

Trial design

Open-label, intra-individual one-way crossover study to assess the potential of a patch formulation containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) to inhibit cytochrome P450 (CYP) 3A4 by evaluating the metabolic interaction between the patch formulation and a single oral dose of 2 mg midazolam (MDZ) as a model substrate in 30 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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