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OpenTrials
Completed

NCT Number: NCT00185419

A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception

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

Completed

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Key information

Conditions

Contraception

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ask Contact, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Chinese female requesting contraceptives

Exclusion criteria

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

Treatment and study plan

Yasmin

Drug

30 µg ethinylestradiol, 3mg drospirenone

Marvelon

Drug

30 µg ethinylestradiol, 150 µg desogestrel

Primary outcomes

  1. 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)

Secondary outcomes

  1. Weight changes

    Time frame: 13 treatment cycles

  2. Contraceptive reliability

    Time frame: 13 treatment cycles

  3. Effects on skin condition

    Time frame: 13 treatment cycles

  4. Changes in MDQ subscale scores

    Time frame: 13 treatment cycles

  5. Adverse Events

    Time frame: the whole study period

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Jan 14, 2009

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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