check_circleStudy Completed

Contraception, Premenstrual Syndrome, Acne

Regulatory Post marketing Surveillance Study on YAZ

Trial purpose

The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.

Key Participants Requirements

Sex

Female

Age

18 - 50 Years

Trial summary

Enrollment Goal
770
Trial Dates
July 2009 - November 2011
Phase
N/A
Could I Receive a placebo
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Korea, Republic Of

Primary Outcome

  • Adverse event collection
    date_rangeTime Frame:
    After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
    enhanced_encryption
    Safety Issue:
    yes
  • Contraception efficacy
    date_rangeTime Frame:
    After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
    enhanced_encryption
    Safety Issue:
    no
  • Drug compliance
    date_rangeTime Frame:
    After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
    enhanced_encryption
    Safety Issue:
    no
  • Release of Premenstrual Dysphoric Disorder (PMDD) or acne
    date_rangeTime Frame:
    After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Number of patients who used YAZ just for contraception
    date_rangeTime Frame:
    At initial visit (Day 0)
    enhanced_encryption
    Safety Issue:
    no
  • Number of patients who used YAZ for PMDD + contraception
    date_rangeTime Frame:
    At initial visit (Day 0)
    enhanced_encryption
    Safety Issue:
    no
  • Number of patients who used YAZ for Acne + contraception
    date_rangeTime Frame:
    At initial visit (Day 0)
    enhanced_encryption
    Safety Issue:
    no

Trial design

Regulatory Post marketing Surveillance Study on YAZ
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A