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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

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

U.S. FDA Resources

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
Active Comparator: Arm 1	Drug: Yasmin 30 µg ethinylestradiol, 3mg drospirenone
Active Comparator: Arm 2	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

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:	NCT00185419 History of Changes
Other Study ID Numbers:	91330, 308062
Study First Received:	September 13, 2005
Last Updated:	January 13, 2009
Health Authority:	China: State Food and Drug Administration

Additional relevant MeSH terms:

Ethinyl Estradiol
Desogestrel
Drospirenone
Drospirenone and ethinyl estradiol combination
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

Aldosterone Antagonists
Hormone Antagonists
Progestins
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012