Comparative Trial in Hormone Withdrawal Associated Symptoms

PHASE3CompletedINTERVENTIONAL
Enrollment

592

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2011

Conditions
Oral Contraceptive
Interventions
DRUG

EE20/DRSP (YAZ, BAY86-5300)

4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days

DRUG

Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)

4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days

Trial Locations (44)

2000

Rosario

3010

Bern

4031

Basel

9007

Sankt Gallen

10330

Bangkok

10700

Bangkok

20132

Milan

30459

Hanover

39003

Tábor

39126

Magdeburg

50134

Florence

53100

Siena

69115

Heidelberg

90110

Songkhla

90763

Fürth

117036

Moscow

123995

Moscow

177997

Moscow

4790711

Temuco

7510025

Santiago

C1425ASQ

Buenos Aires

836-0156

Santiago

838-0456

Santiago

Unknown

Santiago

Bucaramanga

Bogotá

Medellín

Manila

Pasig

Caracas

602 00

Brno

120 00

Prague

04207

Leipzig

07747

Jena

1649-035

Lisbon

3000-061

Coimbra

4200-319

Porto

100-380

Seoul

138-736

Seoul

110-744

Seoul

135-710

Seoul

LS2 9AE

Leeds

L20 5DQ

Liverpool

W12 0HS

London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY