Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
Leiomyoma
Interventions
DRUG

Vilaprisan (BAY1002670)

Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks)

DRUG

Vilaprisan (BAY1002670

Placebo (12 weeks),Vilaprisan (12 weeks)

DRUG

Vilaprisan (BAY1002670

Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)

DRUG

Vilaprisan (BAY1002670)

Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)

DRUG

Ulipristal

Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)

DRUG

Ulipristal

Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)

DRUG

Ulipristal

Ulipristal (12 weeks), treatment break, Placebo (12 weeks)

Trial Locations (64)

1000

Bruxelles - Brussel

1036

Budapest

1090

Vienna

1478

Lørenskog

1504

Sofia

1605

Fredrikstad

1606

Sofia

2650

Edegem

3300

Tienen

4011

Stavanger

4024

Debrecen

4032

Debrecen

5221

Nesttun

5800

Pleven

6000

Stara Zagora

6020

Innsbruck

8036

Graz

9500

Villach

10787

Berlin

13000

Prague

20100

Turku

28023

Aravaca

28500

Pori

30708

Pilsen

37001

České Budějovice

38889

Blankenburg

39701

Písek

41124

Modena

46010

Valencia

46026

Valencia

90185

Umeå

95123

Catania

625 00

Brno

772 00

Olomouc

775 20

Olomouc

120 00

Prague

180 81

Prague

00610

Helsinki

01307

Dresden

06406

Bernburg

H-6600

Szentes

09042

Cagliari

LT-05263

Vilnius

LT-08217

Vilnius

LT-10207

Vilnius

1315 RA

Almere Stad

6419 PC

Heerlen

3435 CM

Nieuwegein

8025 AB

Zwolle

15- 224

Bialystok

90-602

Lodz

20-093

Lublin

20-632

Lublin

02-507

Warsaw

3000-075

Coimbra

1449-005

Lisbon

4202-451

Porto

08003

Barcelona

118 83

Stockholm

171 76

Stockholm

HA1 3UJ

Harrow

N19 5NF

London

NG7 2UH

Nottingham

PO6 3LY

Portsmouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY