Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding

PHASE3CompletedINTERVENTIONAL
Enrollment

339

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Metrorrhagia
Interventions
DRUG

EV/DNG (Qlaira, Natazia, BAY86-5027)

2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo. A blister card consists of 28 pills, taken orally once a day for 7 cycles of 28 days each.

DRUG

placebo

Matching placebo to be taken orally daily for 7 cycles of 28 days each.

Trial Locations (41)

100

Taipei

10330

Bangkok

10700

Bangkok

11217

Taipei

40705

Taichung

100026

Beijing

100034

Beijing

100044

Beijing

100730

Beijing

110004

Shenyang

116011

Dalian

117049

Moscow

117415

Moscow

153045

Ivanovo

169608

Singapore

194354

Saint Petersburg

199034

Saint Petersburg

200030

Shanghai

229899

Singapore

250012

Jinan

266071

Qingdao

300193

Tianjin

300211

Tianjin

350012

Krasnodar

400010

Chongqing

410013

Changsha

421001

Hengyang

430030

Wuhan

430032

Wuhan

510120

Guangzhou

530021

Nanning

610041

Chengdu

610072

Chengdu

664003

Irkutsk

710032

Xi'an

2100129

Shanghai

050051

Shijiazhuang

Unknown

Changchun

Manila

Quezon City

Tainan City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY