Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis

PHASE3CompletedINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

March 31, 2014

Study Completion Date

December 31, 2014

Conditions
Endometriosis
Interventions
DRUG

EE20/DRSP(BAY86-5300)

One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day

DRUG

Placebo

One tablet (no active ingredient) / day and one tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day, for the first 24 weeks and the later 28 weeks, respectively

DRUG

Dienogest

Dienogest 1mg twice a day (bid)

Trial Locations (32)

446-8510

Anjo

491-8551

Ichinomiya

451-8511

Nagoya

460-0011

Nagoya

464-0066

Nagoya

270-2267

Matsudo

910-0845

Fukui-shi

910-8526

Fukui-shi

500-8717

Gifu

370-0883

Takasaki

664-8540

Itami

666-0125

Kawanishi

654-0047

Kobe

920-8530

Kanazawa

247-8533

Kamakura

212-0016

Kawasaki

230-0001

Yokohama

231-0023

Yokohama

530-0001

Osaka

530-0013

Osaka

542-0086

Osaka

560-0022

Toyonaka

364-8501

Kitamoto

112-0014

Bunkyo

104-0061

Chuo-ku

183-0056

Fuchū

192-0046

Hachiōji

194-0022

Machida

105-0001

Minato

107-0051

Minato

188-0011

Nishitōkyō

175-0092

tabashi City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY