Study Completed

Contraception, Heavy menstrual bleeding (HMB)

Bayer Identifier:

91516

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2006-004966-14

EU CT Number:

Not Available

DUB/OC: QT prolongation

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

February 2007 - September 2007

Phase

Phase 1

Could I Receive a placebo

N/A

Products

Natazia/Qlaira (EV/DNG, BAY86-5027)

Accepts Healthy Volunteer

N/A

Where to participate

Status	Institution	Location
Completed	Bayer Pharma AG	Berlin, 13353, Germany

Trial design

Double-blind, double-dummy, placebo-controlled, 4-way cross-over study to investigate QT/QTc prolonging effects in 12-lead ECG after once daily oral dosing over 4 days of drug product SH T 00658M (containing 3 mg dienogest and 2 mg estradiol valerate) and a supra-therapeutic dose of 10 mg dienogest in comparison to placebo and to a single dose of 400 mg moxifloxacin as an openlabel positive control in 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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