409
Participants
Start Date
September 8, 2008
Primary Completion Date
May 10, 2011
Study Completion Date
May 10, 2011
Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo
Ortho Tri Cyclen Lo
Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo
Philadelphia
Decatur
Jacksonville
West Palm Beach
Clearwater
Bristol
Memphis
Columbus
Cincinnati
Fishers
Indianapolis
South Bend
La Crosse
Chesterfield
St Louis
Lincoln
Metairie
Houston
Littleton
Denver
Denver
Idaho Falls
Boise
Boise
Phoenix
Las Vegas
Santa Monica
Encinitas
San Diego
Independence
Winston-Salem
Spokane
New Brunswick
Portland
Langley
Bathurst
St. John's
Halifax
Corunna
Downsview
Hamilton
Hamilton
Newmarket
Ottawa
Sarnia
Toronto
Toronto
Woodstock
Charlottetown
Drummondville
Mirabel
Pointe-Claire
Pointe-Claire
Shawinigan
Ste-Foy
Regina
Saskatoon
Saskatoon
Québec
Lead Sponsor
Bayer
INDUSTRY