A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185419

Purpose

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

Condition	Intervention	Phase
Contraception	Drug: Yasmin Drug: Marvelon	Phase III

MedlinePlus related topics: Birth Control

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Randomised, Parallel-Group Comparison to Investigate the Efficacy of Yasmin® (30 µg Ethinylestradiol, 3mg Drospirenone) and Marvelon® (30 µg Ethinylestradiol, 150 µg Desogestrel) on Cycle Control in Healthy Chinese Women Over 13 Cycles

Further study details as provided by Bayer:

Primary Outcome Measures:

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. [ Time Frame: 13 treatment cycles (1 cycle= 28 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Weight changes [ Time Frame: 13 treatment cycles ] [ Designated as safety issue: No ]
Contraceptive reliability [ Time Frame: 13 treatment cycles ] [ Designated as safety issue: No ]
Effects on skin condition [ Time Frame: 13 treatment cycles ] [ Designated as safety issue: No ]
Changes in MDQ subscale scores [ Time Frame: 13 treatment cycles ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: the whole study period ] [ Designated as safety issue: Yes ]

Enrollment:	842
Study Start Date:	November 2003
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: Yasmin 30 µg ethinylestradiol, 3mg drospirenone
Arm 2: Active Comparator	Drug: Marvelon 30 µg ethinylestradiol, 150 µg desogestrel

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.

Eligibility

Ages Eligible for Study:	20 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Chinese female requesting contraceptives

Exclusion Criteria:

Vascular, metabolic, hepatic, renal, oncologic and other diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185419

Locations

China

ask Contact, China

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91330, 308062
Study First Received:	September 13, 2005
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00185419
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Desogestrel
Estradiol 3-benzoate
Estradiol valerate
Drospirenone
Ethinyl Estradiol

Estradiol 17 beta-cypionate
Healthy
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female

Reproductive Control Agents
Hormones
Pharmacologic Actions
Aldosterone Antagonists
Therapeutic Uses
Progestins
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 14, 2009