check_circleStudy Completed

contraception

Bayer Identifier:

91353

ClinicalTrials.gov Identifier:

NCT00185484

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy and safety oral contraceptive study

Trial purpose

The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Healthy woman requesting contraception
    - Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)
  • - Any conditions might interfere study outcome

Trial summary

Enrollment Goal
1113
Trial Dates
March 2004 - January 2006
Phase
Phase 3
Could I Receive a placebo
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
Yes

Primary Outcome

  • Rate of unintended pregnancies (Pearl index)
    date_rangeTime Frame:
    13 cycles of 28 days
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Physical and gynecological examination
    date_rangeTime Frame:
    screening, cycle 6 and final examination
    enhanced_encryption
    Safety Issue:
    None
  • Vital signs
    date_rangeTime Frame:
    each visit
    enhanced_encryption
    Safety Issue:
    None
  • Body weight
    date_rangeTime Frame:
    each visit
    enhanced_encryption
    Safety Issue:
    None
  • Cervical smear
    date_rangeTime Frame:
    each visit
    enhanced_encryption
    Safety Issue:
    None

Trial design

Multi-center, open, uncontrolled study to investigate the efficacy and safety of the oral contraceptive SH T 186 D containing 0.02 mg ethinylestradiol-b-cyclodextrin clathrate and 3 mg drospirenone in a 24-day regimen for 13 cycles in 1010 healthy female volunteers
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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