Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

955

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Contraception
Interventions
DRUG

EV/DNG (Qlaira, BAY86-5027)

Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days)

Trial Locations (39)

100

Taipei

116

Taipei

333

Taoyuan District

10330

Bangkok

10700

Bangkok

11217

Taipei

40705

Taichung

50200

Chiang Mai

80756

Kaohsiung City

100044

Beijing

100730

Beijing

110004

Shenyang

116011

Dalian

132001

Karnāl

200025

Shanghai

200030

Shanghai

200127

Shanghai

210009

Nanjing

250012

Jinan

300211

Tianjin

325027

Wenzhou

400016

Chongqing

400038

Chongqing

400042

Chongqing

410013

Changsha

411001

Pune

411004

Pune

421001

Hengyang

430030

Wuhan

430032

Wuhan

500003

Secunderabad

510120

Guangzhou

510405

Guangzhou

610041

Chengdu

2100129

Shanghai

050051

Shijiazhuang

Unknown

Hong Kong

Chandigarh

110 029

New Delhi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY