Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa

PHASE3CompletedINTERVENTIONAL
Enrollment

1,326

Participants

Timeline

Start Date

March 10, 2004

Primary Completion Date

May 21, 2005

Study Completion Date

May 21, 2005

Conditions
Acne Vulgaris
Interventions
DRUG

Valette

1 tablet 0.030 mg ethinylestradiol / 2 mg dienogest + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles

DRUG

Diane

1 tablet 0.035 mg ethinylestradiol / 2 mg cyproterone acetate + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles

DRUG

Placebo

2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles

Trial Locations (62)

10034

Prague

15500

Prague

20319

Lublin

28401

Kutná Hora

28601

Čáslav

33028

Rivne

40010

Ústí nad Labem

43012

Chomutov

44001

Louny

46006

Ternopil

49076

Dnipropetrovsk

56802

Svitavy

58000

Chernivtsi

60631

Poznan

61057

Kharkiv

65006

Odesa

69063

Zaporizhzhia

76000

Ivano-Frankivsk

77900

Olomouc

81130

Lviv

83087

Donetsk

83331

Bratislava

86106

Makiivka

88011

Uzhhorod

90265

Lodz

91017

Luhansk

94201

Alchevs'k

94901

Nitra

95006

Simferopol

97401

Banská Bystrica

107076

Moskva

109004

Moscow

121002

Moskva

121614

Moscow

123182

Moscow

123423

Moscow

125009

Moscow

125047

Moscow

141074

Korolyov

185910

Petrozavodsk

190020

Saint Petersburg

192012

Saint Petersburg

192102

Saint Petersburg

194044

Saint Petersburg

194175

Saint Petersburg

195067

Saint Petersburg

197183

Saint Petersburg

197198

Saint Petersburg

314039

Poltava

274 01

Slaný

86-300

Grudziądz

00710

Warsaw

01456

Warsaw

01684

Warsaw

02722

Warsaw

50-353

Wroclaw

194 291

Saint Petersburg

04015

Kosice-Saca

04066

Košice

01032

Kiev

03035

Kiev

01021

Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY