Effect on Primary Dysmenorrhea

PHASE3CompletedINTERVENTIONAL
Enrollment

507

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Primary Dysmenorrhea
Interventions
DRUG

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval

DRUG

Ethinyl estradiol, Levonorgestrel (Miranova)

Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval

DRUG

Placebo Match to SH T00658ID

Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

DRUG

Placebo Match to SH D593B

Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

Trial Locations (41)

1000

Metro Manila

10126

Torino

15206

Pittsburgh

19114

Philadelphia

20121

Milan

22159

Hamburg

25123

Brescia

27103

Winston-Salem

30328

Sandy Springs

33012

Hialeah

33100

Udine

34748

Leesburg

39126

Magdeburg

40138

Bologna

41124

Modena

45127

Essen

50931

Cologne

53100

Siena

54691

La Crosse

72021

Francavilla Fontana

79106

Freiburg im Breisgau

83404

Idaho Falls

85741

Tucson

92108

San Diego

4790711

Temuco

V3A 4H9

Langley

M5C 2T2

Toronto

H9R 4S3

Pointe-Claire

G1V 4X7

Ste-Foy

S4P 3X1

Regina

Unknown

Santiago

Talcahuano

Cebu

Cebu City

Davao City

Metro Manila

Quezon City

04207

Leipzig

06406

Bernburg

06156

Perugia

00161

Roma

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00909857 - Effect on Primary Dysmenorrhea | Biotech Hunter | Biotech Hunter