check_circleStudy Completed

Contraception, Heavy menstrual bleeding (HMB)

DUB/OC: QT prolongation

Trial purpose

Please see attached Study Results Summary below

Key Participants Requirements

Sex

N/A

Age

45 - 75 Years
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  • -

Trial summary

Enrollment Goal
53
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

StatusInstitutionLocation
Completed
Bayer Pharma AGBerlin, 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