Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap

PHASE2CompletedINTERVENTIONAL
Enrollment

309

Participants

Timeline

Start Date

May 15, 2014

Primary Completion Date

May 4, 2016

Study Completion Date

May 4, 2016

Conditions
Leiomyoma
Interventions
DRUG

BAY1002670

Subjects received 4 milligram (mg) Vilaprisan (VPR) tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.

DRUG

BAY1002670

Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.

DRUG

BAY1002670

Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.

DRUG

BAY1002670

Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.

DRUG

Placebo

Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.

Trial Locations (105)

1070

Bruxelles - Brussel

1200

Bruxelles - Brussel

1504

Sofia

1606

Sofia

1653

Sellebakk

1797

Sofia

3000

Leuven

3010

Bern

4000

Liège

4024

Debrecen

4032

Debrecen

5221

Nesttun

5800

Pleven

6000

Charleroi

Stara Zagora

Kecskemét

6600

Szentes

6725

Szeged

7006

Trondheim

7014

Trondheim

10038

New York

12200

Berlin

12808

Prague

13000

Prague

15206

Pittsburgh

19104

Philadelphia

19114

Philadelphia

20036

Washington D.C.

23507

Norfolk

23538

Lübeck

27612

Raleigh

27713

Durham

28023

Aravaca

30328

Sandy Springs

31241

Ilsede

32207

Jacksonville

32606

Gainesville

33143

South Miami

33324

Plantation

37404

Chattanooga

38889

Blankenburg

39701

Písek

41013

Seville

41014

Seville

43231

Columbus

44195

Cleveland

46017

Valencia

47630

Newburgh

59590

Geseke

60540

Naperville

68510

Lincoln

70072

Marrero

70110

Kuopio

75035

Frisco

75231

Dallas

76199

Karlsruhe

77030

Houston

77054

Houston

80100

Joensuu

80209

Denver

85209

Mesa

85712

Tucson

90100

Oulu

91054

Erlangen

92103

San Diego

92108

San Diego

98105

Seattle

06489

Southington

08057

Moorestown

07753

Neptune City

08901

New Brunswick

97239-3011

Portland

15213-3180

Pittsburgh

R3T 2E8

Winnipeg

L8S 4K1

Hamilton

K1H 7W9

Ottawa

H9R 4S3

Pointe-Claire

G1S 2L6

Québec

370 01

České Budějovice

500 05

Hradec Králové

772 00

Olomouc

02100

Espoo

00260

Helsinki

01307

Dresden

06406

Bernburg

270-2267

Matsudo

820-8505

Iizuka

963-8585

Kōriyama

004-0052

Sapporo

064-0808

Sapporo

920-8530

Kanazawa

856-8562

Ōmura

410-8555

Numazu

115-0053

Kita-ku

164-8541

Nakano-ku

190-8531

Tacchikawa

862-8505

Kumamoto

381-8551

Nagano

0407

Oslo

08028

Barcelona

08035

Barcelona

411 18

Gothenburg

701 85

Örebro

171 76

Stockholm

751 85

Uppsala

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT02131662 - Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap | Biotech Hunter | Biotech Hunter