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GA YAZ ACNE in China Phase III

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00818519
First received: January 6, 2009
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
Results First Received: April 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: EE20/Drospirenone (YAZ, BAY86-5300)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Analyzed: 179 participants randomized, 173 in the FAS (Full Analysis Set): 87 in YAZ, 86 in placebo groups, 143 in the PPS (Per Protocol Set): 74 in YAZ, 69 in placebo groups

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
193 participants screened, 14 failed screening: withdrawal of consent (7), inclusion/exclusion criteria not met (6), participant lost/no further information available (1). study drug intake was unknown (3) and 3 participants to whom study drug was never administered (withdrawal of consent or lost to follow-up) were excluded from FAS.

Reporting Groups
  Description
EE20/Drospirenone (YAZ, BAY86-5300) In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
Placebo The participants of the placebo group received inert but identical-appearing, color-matched tablets.

Participant Flow:   Overall Study
    EE20/Drospirenone (YAZ, BAY86-5300)     Placebo  
STARTED     89 [1]   90 [2]
Participants Received Treatment     87 [3]   86 [3]
COMPLETED     75     71  
NOT COMPLETED     14     19  
Adverse Event                 2                 2  
Lost to Follow-up                 4                 6  
Protocol Violation                 2                 1  
Pregnancy                 0                 1  
Withdrawal by Subject                 4                 9  
participant recovered completely                 1                 0  
participant will leave for long tme                 1                 0  
[1] 2 excluded from FAS because study drug intake unknown or never administered
[2] 4 excluded from FAS because study drug intake unknown or never administered
[3] = Baseline



  Baseline Characteristics
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Reporting Groups
  Description
EE20/Drospirenone (YAZ, BAY86-5300) In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
Placebo The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Total Total of all reporting groups

Baseline Measures
    EE20/Drospirenone (YAZ, BAY86-5300)     Placebo     Total  
Number of Participants  
[units: participants]
 		  87     86     173  
Age [1]
[units: Years]
Mean ± Standard Deviation 		  24.0  ± 5.8     23.4  ± 5.4     23.7  ± 5.6  
Gender  
[units: Participants]
 		     
Female     87     86     173  
Male     0     0     0  
[1] Age of participants was derived from birth date entered onto CRF (Case Report Form)



  Outcome Measures
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1.  Primary:   Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set)   [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ]
  Show Outcome Measure 1

2.  Primary:   Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the PPS (Per Protocol Set)   [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit   [ Time Frame: Screening visit ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1   [ Time Frame: Cycle 1 (Day 15±3 days of Treatment Cycle 1) ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3   [ Time Frame: Cycle 3 (Day 15±3 days of Treatment Cycle 3) ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6   [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) ]
  Show Outcome Measure 6

7.  Secondary:   Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count   [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ]
  Show Outcome Measure 7

8.  Secondary:   Percent Change From Cycle 6 to Baseline in Lesion Count of Papules   [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ]
  Show Outcome Measure 8

9.  Secondary:   Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules   [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ]
  Show Outcome Measure 9

10.  Secondary:   Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules   [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ]
  Show Outcome Measure 10

11.  Secondary:   Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones   [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ]
  Show Outcome Measure 11

12.  Secondary:   Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones   [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ]
  Show Outcome Measure 12

13.  Secondary:   Percentage of Participants Classified as “Improved” According to the Investigator’s Overall Improvement Rating and on the Participant’s Overall Self-Assessment Rating   [ Time Frame: At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle) ]
  Show Outcome Measure 13


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00818519     History of Changes
Other Study ID Numbers: 91772, 311963
Study First Received: January 6, 2009
Results First Received: April 6, 2011
Last Updated: May 31, 2012
Health Authority: China: State Food and Drug Administration (SFDA)