check_circleStudy Completed

Contraception

Bayer Identifier:

91330

ClinicalTrials.gov Identifier:

NCT00185419

EudraCT Number:

Not Available

EU CT Number:

Not Available
A clinical study on Yasmin® vs. Marvelon® in Chinese Women requiring contraception

Trial 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

Key Participants Requirements

Sex

Female

Age

20 - 35 Years
  • - Healthy Chinese female requesting contraceptives
  • - Vascular, metabolic, hepatic, renal, oncologic and other diseases

Trial summary

Enrollment Goal
842
Trial Dates
October 2003 - March 2006
Phase
Phase 3
Could I Receive a placebo
No
Products
Yasmin (EE30/DRSP, BAY86-5131)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
ask Contact, China
Completed
ask Contact, China
Completed
ask Contact, China
Completed
ask Contact, China
Completed
ask Contact, China
Completed
ask Contact, China
Completed
ask Contact, China
Completed
ask Contact, China
Completed
ask Contact, China
Completed
ask Contact, China
Completed
ask Contact, China
Completed
ask Contact, China

Primary Outcome

  • 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.
    date_rangeTime Frame:
    13 treatment cycles (1 cycle= 28 days)
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Weight changes
    date_rangeTime Frame:
    13 treatment cycles
    enhanced_encryption
    Safety Issue:
    no
  • Contraceptive reliability
    date_rangeTime Frame:
    13 treatment cycles
    enhanced_encryption
    Safety Issue:
    no
  • Effects on skin condition
    date_rangeTime Frame:
    13 treatment cycles
    enhanced_encryption
    Safety Issue:
    no
  • Changes in MDQ subscale scores
    date_rangeTime Frame:
    13 treatment cycles
    enhanced_encryption
    Safety Issue:
    no
  • Adverse Events
    date_rangeTime Frame:
    the whole study period
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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