Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

PHASE3CompletedINTERVENTIONAL
Enrollment

231

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

Conditions
Metrorrhagia
Interventions
DRUG

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

1 pill per day taken orally over 7 cycles of 28 pills per cycle

DRUG

Placebo

1 pill per day taken orally over 7 cycles of 28 pills per cycle

Trial Locations (36)

1082

University of Semmelweis, Budapest

2667

Center for Clinical& Basic Research, Pardubice

2921

Selya Janos Hospital, Komárom

3501

Borsod-Abauj-Zemplen County Hospital, Miskolc

6008

King Edward Memorial Hospital, Subiaco

6166

PreCare Trial & Recruitment, Geleen

10629

emovis GmbH, Berlin

15110

Terveystalo Lahti, Lahti

20540

Ylioppilaiden terveydenhoitosäätiö, Turku, Turku

22185

Skånes Universitetssjukhus, Lund

30459

Praxis Hr. Dr. K. Greven, Hanover

33100

Koskiklinikka, Tampere

37001

Gynekologicka ambulance Vanda Horejsi, MD, České Budějovice

39701

Gynekologicko-poradnicka ambulance Dr. Hlavackova, Písek

76199

Praxis Hr. Dr. U. Kohoutek, Karlsruhe

76287

Praxis Hr. Dr. S. Schönian, Rheinstetten

NSW 2131

Private Practice Dr. Ian Fraser, Ashfield

170 00

Lekarsky dum Praha 7 a.s.Gynekologicka ambulance Dr. Jenicek, Prague

02100

Adenova Lääkärikeskus Oy, Espoo

01067

ClinPharm International GmbH, Dresden

7511 JX

Medisch Spectrum Twente, Locatie Ariensplein, Enschede

6525 EC

Menox BV, Nijmegen

15-435

Poliklinika Ginekologiczna- Poloznicza, Bialystok

93-338

Instytut Centrum Zdrowia Matki Polki, Lodz

20-081

SPSK nr 1, Lublin

60-525

Szpital Kliniczny nr 3, Poznan

02-507

CSK MSWiA, Warsaw

141 86

Karolinska Universitetssjukhuset Huddinge, Stockholm

SE-751 85

Akademiska Sjukhuset, Uppsala

01030

Dept. of obstetrics and gynaecology, Kiev

04050

Instr. of Pediatrics, Obstetrics & Gynecology, Kiev

04210

Kyiv Medical Academy of Postdyploma Education, Kiev

Unknown

Lviv Regional Center Perinatal Center, Lviv

SK8 5LL

Bridge House Medical Centre, Cheadle

LU4 0DZ

Luton & Dunstable Hospital, Luton

HA6 2RN

MeDiNova Research, Northwood

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00307801 - Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding | Biotech Hunter | Biotech Hunter