Clinical trial NCT00280657: Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa
Official title: Multicenter, Double-blind, Double-dummy, Randomized Parallel Group Study to Evaluate the Safety and Efficacy of SH D 00659 E for 6 Treatment Cycles in Female Patients With Acne Papulopustulosa in Comparison to SH D 00659 G and Placebo.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne papulopustulosa
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-01-23
Enrollment: 1326
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Patients with mild to moderate facial papulopustular acne

Exclusion Criteria:

* Contraindication against use of hormonal contraceptives

Primary outcomes:
measure: Change in lesions
timeFrame: 6 months
Secondary outcomes:
measure: ISGA
timeFrame: 6 months
measure: Parameters of safety and tolerability
timeFrame: 6 months
Other outcomes:
Locations:
city: Caslav
country: Czechia
city: Chomutov
country: Czechia
city: Kutna Hora
country: Czechia
city: Louny
country: Czechia
city: Olomouc
country: Czechia
city: Praha
country: Czechia
city: Praha
country: Czechia
city: Slany
country: Czechia
city: Svitavy
country: Czechia
city: Usti nad Labem
country: Czechia
city: Grudziadz
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Korolev
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moskva
country: Russian Federation
city: Moskva
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Sankt-Peterburg
country: Russian Federation
city: Sankt-Peterburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Kosice-Saca
country: Slovakia
city: Kosice
country: Slovakia
city: Nitra
country: Slovakia
city: Alchevsk
country: Ukraine
city: Chernivtsi
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Lugansk
country: Ukraine
city: Lviv
country: Ukraine
city: Makeevka
country: Ukraine
city: Odessa
country: Ukraine
city: Poltava
country: Ukraine
city: Rivne
country: Ukraine
city: Simferopol
country: Ukraine
city: Ternopil
country: Ukraine
city: Uzhhorod
country: Ukraine
city: Zaporizhzhia
country: Ukraine
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: