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

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

February 28, 2010

Study Completion Date

March 31, 2010

Conditions
ContraceptionOvulation Inhibition
Interventions
DRUG

Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)

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

DRUG

Estradiol Valerate (EV) (BAY86-4980)

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

DRUG

Levomefolate Calcium (BAY86-7660)

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