YAZ, Oral Contraceptive Registration in China - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00819312

Purpose

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.

Condition	Intervention	Phase
Contraception	Drug: YAZ (SH T00186, BAY86-5300)	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Ethinyl estradiol 1,2-Dihydrospirorenone

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bleeding pattern indices [ Time Frame: 13 cycles ] [ Designated as safety issue: No ]
Cycle control parameters [ Time Frame: 13 cycles ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]
Laboratory tests [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]

Enrollment:	675
Study Start Date:	December 2008
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1	Drug: YAZ (SH T00186, BAY86-5300) 20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819312

Locations

China, Guangdong

Guangzhou, Guangdong, China, 510120

Guangzhou, Guangdong, China
China, Hubei

Wuhan, Hubei, China, 430022
China, Jiangsu

Nanjing, Jiangsu, China, 210009

Nanjing, Jiangsu, China, 210006

Yangzhou, Jiangsu, China, 225001
China, Liaoning

Shenyang, Liaoning, China, 110004
China, Shandong

Jinan, Shandong, China
China, Shanxi

Xi An, Shanxi, China, 710032
China, Sichuan

Chengdu, Sichuan, China
China

Beijing, China, 100034

Beijing, China, 100044

Chongqing, China, 400010

Chongqing, China

Shanghai, China, 200127

Shanghai, China, 200011
Hong Kong

Hongkong, Hong Kong

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier:	NCT00819312 History of Changes
Other Study ID Numbers:	91619, 311041
Study First Received:	January 5, 2009
Last Updated:	February 22, 2011
Health Authority:	China: State Food and Drug Administration (SFDA)

Keywords provided by Bayer:

Contraceptives,
Oral Hormonal;
Contraceptive Methods;
Female

Additional relevant MeSH terms:

Contraceptive Agents
Contraceptives, Oral
Ethinyl Estradiol
Drospirenone
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions

Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Aldosterone Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012