NCT00280657CompletedPhase 3
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 1,326
- Primary Endpoint
- Change in lesions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 16 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with mild to moderate facial papulopustular acne
Exclusion Criteria
- •Contraindication against use of hormonal contraceptives
Arms & Interventions
Arm 1
Experimental
Intervention: Valette (Drug)
Arm 2
Active Comparator
Intervention: Diane (Drug)
Arm 3
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in lesions
Time Frame: 6 months
Secondary Outcomes
- Parameters of safety and tolerability(6 months)
- ISGA(6 months)
Investigators
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