A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185419
First received: September 13, 2005
Last updated: January 13, 2009
Last verified: January 2009
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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 3 |
| 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:
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 More Information
Additional Information:
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: 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 May 23, 2013