Contraception
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in healthy Chinese women
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.
Interventions
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Chinese female requesting contraceptives
Exclusion criteria
* Vascular, metabolic, hepatic, renal, oncologic and other diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is the comparison of cycle control from randomisation to cycle 13. This will be based on the number of subjects reporting at least 1 unexpected intracyclic bleeding episode between cycles 2 to 13. | 13 treatment cycles (1 cycle= 28 days) |
Secondary
| Measure | Time frame |
|---|---|
| Weight changes | 13 treatment cycles |
| Contraceptive reliability | 13 treatment cycles |
| Effects on skin condition | 13 treatment cycles |
| Changes in MDQ subscale scores | 13 treatment cycles |
| Adverse Events | the whole study period |
Countries
China
Outcome results
None listed