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Completed

NCT Number: NCT00819312

YAZ, Oral Contraceptive Registration in China

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.

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

YAZ (SH T00186, BAY86-5300)

Drug

20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd

Primary outcomes

  1. The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment.

    Time frame: 13 cycles (1 cycle= 28 days)

Secondary outcomes

  1. Bleeding pattern indices

    Time frame: 13 cycles

  2. Cycle control parameters

    Time frame: 13 cycles

  3. Adverse events

    Time frame: Whole study period

  4. Laboratory tests

    Time frame: Whole study period

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 8, 2009
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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