Study Completed

Hormone replacement therapy (HRT)

Bayer Identifier:

91576

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2008-004692-22

EU CT Number:

Not Available

Angeliq low/low: Relative Bioavailability

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

June 2009 - September 2009

Phase

Phase 1

Could I Receive a placebo

N/A

Products

Low-Dose 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, crossover study to investigate the relative bioavailability of estradiol (E2) and drospirenone (DRSP) after single oral administration of a tablet containing 0.5 mg E2 + 0.5 mg DRSP, a tablet containing 0.5 mg E2 + 0.25 mg DRSP and a microcrystalline suspension containing 0.5 mg E2 + 0.5 mg DRSP 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

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.