Contraception
Conditions
Keywords
Contraceptives,, Oral Hormonal;, Contraceptive Methods;, Female
Brief summary
The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.
Interventions
DRUGYAZ (SH T00186, BAY86-5300)
20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy women between 18 and 45 requesting oral contraception. * Smokers may not exceed 30 years of age.
Exclusion criteria
* The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study. * Pregnancy, lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment) * Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea * Any disease or condition that may worsen under hormonal treatment * Other contraceptive methods such as sterilization or IUD/IUS * Substantial overweight (BMI \> 30 kg/m2).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment. | 13 cycles (1 cycle= 28 days) |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding pattern indices | 13 cycles |
| Cycle control parameters | 13 cycles |
| Adverse events | Whole study period |
| Laboratory tests | Whole study period |
Countries
China, Hong Kong
Outcome results
None listed