Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00280657

Purpose

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

Condition	Intervention	Phase
Acne Vulgaris	Drug: Valette Drug: Diane Drug: Placebo	Phase III

MedlinePlus related topics: Acne

Drug Information available for: Ethinyl estradiol Cyproterone acetate Cyproterone Dienogest

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Bayer:

Primary Outcome Measures:

Secondary Outcome Measures:

ISGA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Parameters of safety and tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	1326
Study Start Date:	March 2004
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	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
Arm 2: Active Comparator	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
Arm 3: Placebo Comparator	Drug: Placebo 2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles

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:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280657

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91299, 307760
Study First Received:	January 20, 2006
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00280657
Health Authority:	Czech Republic: State Institute for Drug Control; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Pharmacological Committee, Ministry of Health; Slovakia: State Institute for Drug Control; Ukraine: State Pharmacological Center - Ministry of Health; United States: Food and Drug Administration

Keywords provided by Bayer:

Acne papulopustulosa

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Facies
Skin Diseases
Cyproterone Acetate
Cyproterone

Ethinyl Estradiol
Sebaceous Gland Diseases
Diane
Dienogest
Acne Vulgaris

Additional relevant MeSH terms:

Acneiform Eruptions

ClinicalTrials.gov processed this record on January 15, 2009