Trial Condition(s):

Metrorrhagia

Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Bayer Identifier:

91470

ClinicalTrials.gov Identifier:

NCT00307801

EudraCT Number:

2005-004340-32

Study Completed

Trial Purpose

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

Inclusion Criteria
- Women 18 years or older 
 - And with a diagnosis of dysfunctional uterine bleeding without organic pathology 
 - And with at least one of the following symptoms: prolonged, frequent or excessive bleeding.
Exclusion Criteria
- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study. 
 - Women with a history of endometrial ablation or dilatation and curettage within 2 months prior to study start will be excluded.

Trial Summary

Enrollment Goal
231
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Gynekologicka ambulance Vanda Horejsi, MD

Ceske Budejovice, Czech Republic, 37001

Status
Completed
 
Locations

Adenova Lääkärikeskus Oy

Espoo, Finland, 02100

Status
Completed
 
Locations

Koskiklinikka

Tampere, Finland, 33100

Status
Completed
 
Locations

Terveystalo Lahti

Lahti, Finland, 15110

Status
Completed
 
Locations

Ylioppilaiden terveydenhoitosäätiö, Turku

Turku, Finland, 20540

Status
Completed
 
Locations

emovis GmbH

Berlin, Germany, 10629

Status
Completed
 
Locations

ClinPharm International GmbH

Dresden, Germany, 01067

Status
Completed
 
Locations

Praxis Hr. Dr. U. Kohoutek

Karlsruhe, Germany, 76199

Status
Completed
 
Locations

Praxis Hr. Dr. S. Schönian

Rheinstetten, Germany, 76287

Status
Completed
 
Locations

Praxis Hr. Dr. K. Greven

Hannover, Germany, 30459

Status
Completed
 
Locations

Selya Janos Hospital

Komarom, Hungary, 2921

Status
Completed
 
Locations

University of Semmelweis

Budapest, Hungary, 1082

Status
Completed
 
Locations

Medisch Spectrum Twente, Locatie Ariensplein

Enschede, Netherlands, 7511 JX

Status
Completed
 
Locations

PreCare Trial & Recruitment

Geleen, Netherlands, 6166

Status
Completed
 
Locations

Menox BV

Nijmegen, Netherlands, 6525 EC

Status
Completed
 
Locations

CSK MSWiA

Warszawa, Poland, 02-507

Status
Completed
 
Locations

Center for Clinical& Basic Research

Pardubice, Czech Republic, 2667

Status
Completed
 
Locations

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

Praha 7, Czech Republic, 170 00

Status
Completed
 
Locations

Gynekologicko-poradnicka ambulance Dr. Hlavackova

Pisek, Czech Republic, 39701

Status
Completed
 
Locations

Borsod-Abauj-Zemplen County Hospital

Miskolc, Hungary, 3501

Status
Completed
 
Locations

Poliklinika Ginekologiczna- Poloznicza

Bialystok, Poland, 15-435

Status
Completed
 
Locations

Szpital Kliniczny nr 3

Poznan, Poland, 60-525

Status
Completed
 
Locations

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden, 141 86

Status
Completed
 
Locations

Akademiska Sjukhuset

Uppsala, Sweden, SE-751 85

Status
Completed
 
Locations

Bridge House Medical Centre

Cheadle, United Kingdom, SK8 5LL

Status
Completed
 
Locations

MeDiNova Research

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
Locations

Private Practice Dr. Ian Fraser

Ashfield, Australia, NSW 2131

Status
Completed
 
Locations

Lviv Regional Center Perinatal Center

Lviv, Ukraine

Status
Completed
 
Locations

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland, 93-338

Status
Completed
 
Locations

SPSK nr 1

Lublin, Poland, 20-081

Status
Completed
 
Locations

Skånes Universitetssjukhus

Lund, Sweden, 22185

Status
Completed
 
Locations

Luton & Dunstable Hospital

Luton, United Kingdom, LU4 0DZ

Status
Completed
 
Locations

King Edward Memorial Hospital

Subiaco, Australia, 6008

Status
Completed
 
Locations

Kyiv Medical Academy of Postdyploma Education

Kiev, Ukraine, 04210

Status
Completed
 
Locations

Dept. of obstetrics and gynaecology

Kiev, Ukraine, 01030

Status
Completed
 
Locations

Instr. of Pediatrics, Obstetrics & Gynecology

Kiev, Ukraine, 04050

Status
Completed
 

Trial Design