NCT00280657
Completed
Phase 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.
Overview
- Phase
- Phase 3
- Intervention
- Valette
- Conditions
- Acne Vulgaris
- Sponsor
- Bayer
- Enrollment
- 1326
- Primary Endpoint
- Change in lesions
- Status
- Completed
- Last Updated
- 2 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with mild to moderate facial papulopustular acne
Exclusion Criteria
- •Contraindication against use of hormonal contraceptives
Arms & Interventions
Arm 1
Intervention: Valette
Arm 2
Intervention: Diane
Arm 3
Intervention: Placebo
Outcomes
Primary Outcomes
Change in lesions
Time Frame: 6 months
Secondary Outcomes
- Parameters of safety and tolerability(6 months)
- ISGA(6 months)
Similar Trials
Unknown
Phase 3
Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral ContraceptionOral ContraceptiveNCT02021097Regenex Pharmaceutical, China1,008
Completed
Phase 3
Effect on Primary DysmenorrheaPrimary DysmenorrheaNCT00909857Bayer507
Completed
Phase 3
Effects of SH T00658ID on LibidoContraceptionLibidoNCT00764881Bayer217
Completed
Phase 3
Pearl Index Study With Low Dose Combined Oral ContraceptiveContraceptionNCT00220324Bayer840
Withdrawn
Phase 3
Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017)ContraceptionNCT01723579Organon and Co