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NCT00280657 Clinical Trial

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

Acne Vulgaris Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00280657
Other study ID # 91299
Secondary ID 307760
Status Completed
Phase Phase 3
First received
Last updated
Start date March 10, 2004
Est. completion date May 21, 2005

Study information
Verified date June 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1326
Est. completion date May 21, 2005
Est. primary completion date May 21, 2005
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 45 Years
Eligibility Inclusion Criteria: - Patients with mild to moderate facial papulopustular acne Exclusion Criteria: - Contraindication against use of hormonal contraceptives

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Czechia,  Poland,  Russian Federation,  Slovakia,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in lesions 6 months
Secondary ISGA 6 months
Secondary Parameters of safety and tolerability 6 months
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