Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

January 31, 2009

Study Completion Date

August 31, 2009

Conditions
Dysmenorrhea
Interventions
DRUG

DRSP 3 mg/EE 20 µg (13 cycles)

1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)

DRUG

DRSP 3 mg/EE 30 µg (6 cycles)

1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)

Trial Locations (26)

460-0007

Nagoya

460-0011

Nagoya

464-0066

Nagoya

371-0024

Maebashi

370-0883

Takasaki

650-0021

Kobe

663-8204

Nishinomiya

242-0007

Yamato

231-0861

Yokohama

980-0021

Sendai

981-0933

Sendai

984-0042

Sendai

530-0013

Osaka

534-0014

Osaka

560-0022

Toyonaka

104-0061

Chuo-ku

192-0046

Hachiōji

194-0022

Machida

180-0003

Musashino

144-0052

Ōta-ku

156-0042

Setagaya-ku

157-0066

Setagaya-ku

150-0013

Shibuya-ku

140-0013

Shinagawa-ku

167-0051

Suginami-ku

171-0021

Toshima-ku

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY