Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

December 31, 2009

Study Completion Date

January 31, 2010

Conditions
Pharmacology, Clinical
Interventions
DRUG

BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium

Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days

DRUG

BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)

Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days

DRUG

BAY 86-7660,levomefolate calcium

Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days

Trial Locations (1)

89231

Neu-Ulm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY