Study Completed

Hormone replacement therapy (HRT)

Bayer Identifier:

91461

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2005-001953-96

EU CT Number:

Not Available

PK eval. of Angeliq - rel. BA/multiple PK

Trial purpose

Please see attached Study Results Summary below

Key Participants Requirements

Sex

N/A

Age

45 - 75 Years

Trial summary

Enrollment Goal

Trial Dates

September 2005 - December 2005

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

Trial design

Open-label, randomized, cross-over study to evaluate the relative bioavailability (single dose, 1 tablet, in comparison to microcrystalline suspension) and to describe the pharmacokinetics (multiple dose, 28 days) of 17beta -estradiol (E2) and drospirenone (DRSP) after oral administration of a tablet formulation containing 1 mg E2 + 0.5 mg DRSP (SH T641A) in 18 healthy 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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