YAZ, Oral Contraceptive Registration in China

Contraception Clinical Trial

Official title:

A Multicenter, Open-label, Single-arm Study to Investigate the Efficacy and Safety of the Oral Contraceptive YAZ (20 μg Ethinylestradiol, 3 mg Drospirenone) for 13 Cycles in 670 Healthy Chinese Female Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819312
• Other study ID #: 91619
• Secondary ID: 311041
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2009
• Last updated: January 27, 2013
• Start date: December 2008
• Est. completion date: January 2011

Study information

• Verified date: January 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Food and Drug Administration (SFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 675
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• YAZ (SH T00186, BAY86-5300)
20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Bleeding pattern indices		13 cycles	No
Secondary	Cycle control parameters		13 cycles	No
Secondary	Adverse events		Whole study period	Yes
Secondary	Laboratory tests		Whole study period	Yes

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