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GA YAZ ACNE in China Phase III

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00818519
Recruitment Status : Completed
First Posted : January 7, 2009
Results First Posted : June 9, 2011
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: EE20/Drospirenone (YAZ, BAY86-5300)
Drug: Placebo
Enrollment 179
Recruitment Details 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 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.
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description 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). The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Period Title: Overall Study
Started 89 [1] 90 [2]
Participants Received Treatment 87 [3] 86 [3]
Completed 75 71
Not Completed 14 19
Reason Not Completed
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
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo Total
Hide Arm/Group Description 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). The participants of the placebo group received inert but identical-appearing, color-matched tablets. Total of all reporting groups
Overall Number of Baseline Participants 87 86 173
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 86 participants 173 participants
24.0  (5.8) 23.4  (5.4) 23.7  (5.6)
[1]
Measure Description: Age of participants was derived from birth date entered onto CRF (Case Report Form)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 86 participants 173 participants
Female
87
 100.0%
86
 100.0%
173
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 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)
Hide Description Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 87 86
Mean (Standard Deviation)
Unit of Measure: Percent change
66.79  (31.45) 37.71  (118.73)
2.Primary Outcome
Title 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)
Hide Description Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 74 69
Mean (Standard Deviation)
Unit of Measure: Percent change
72.63  (27.45) 55.56  (32.50)
3.Secondary Outcome
Title 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set at screening
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 87 86
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 0.0
4.Secondary Outcome
Title 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, all participants with data for Cycle 1
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 84 84
Measure Type: Number
Unit of Measure: Percentage of participants
1.2 0.0
5.Secondary Outcome
Title 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, all participants with data for Cycle 3
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 81 81
Measure Type: Number
Unit of Measure: Percentage of participants
2.5 4.9
6.Secondary Outcome
Title 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, all participants with data for Cycle 6
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 73 71
Measure Type: Number
Unit of Measure: Percentage of participants
49.3 18.3
7.Secondary Outcome
Title Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count
Hide Description Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (lesion count at Baseline - lesion count at Cycle 6)/(lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (due to missing data number of participants differs from number at Baseline)
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 75 71
Mean (Standard Deviation)
Unit of Measure: Percent change
Inflammatory lesion count 75.49  (28.11) 60.88  (29.92)
Non-inflammatory lesion count 69.27  (33.75) 50.24  (49.93)
8.Secondary Outcome
Title Percent Change From Cycle 6 to Baseline in Lesion Count of Papules
Hide Description Acne lesions were counted by the trained designee over the entire face. All papules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (papule count at Baseline - papule count at Cycle 6)/(papule count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (due to missing data number of participants differs from number at Baseline)
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 75 71
Mean (Standard Deviation)
Unit of Measure: Percent change
72.36  (31.32) 55.03  (40.19)
9.Secondary Outcome
Title Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules
Hide Description Acne lesions were counted by the trained designee over the entire face. All pustules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (pustule count at Baseline - pustule count at Cycle 6)/(pustule count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (due to missing data number of participants differs from number at Baseline)
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 64 61
Mean (Standard Deviation)
Unit of Measure: Percent change
79.88  (40.83) 78.15  (34.37)
10.Secondary Outcome
Title Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules
Hide Description Acne lesions were counted by the trained designee over the entire face. All nodules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (nodule count at Baseline - nodule count at Cycle 6)/(nodule count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (due to missing data number of participants differs from number at Baseline)
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: Percent change
95.83  (18.45) 95.00  (20.13)
11.Secondary Outcome
Title Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones
Hide Description Acne lesions were counted by the trained designee over the entire face. All open comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (open comedone count at Baseline -open comedone count at Cycle 6)/(open comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (due to missing data number of participants differs from number at Baseline)
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 72 69
Mean (Standard Deviation)
Unit of Measure: Percent change
24.03  (289.46) 38.31  (94.52)
12.Secondary Outcome
Title Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones
Hide Description Acne lesions were counted by the trained designee over the entire face. All closed comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (closed comedone count at Baseline - closed comedone count at Cycle 6)/(closed comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (due to missing data number of participants differs from number at Baseline)
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 75 70
Mean (Standard Deviation)
Unit of Measure: Percent change
69.52  (42.24) 48.73  (61.16)
13.Secondary Outcome
Title Percentage of Participants Classified as “Improved” According to the Investigator’s Overall Improvement Rating and on the Participant’s Overall Self-Assessment Rating
Hide Description The proportion of participants rated as “improved” comprises those with complete remission, excellent, marked, or moderate improvement according to the Investigator’s Overall Improvement Rating and those with excellent, good, or fair improvement the Participant’s Overall Self-Assessment Rating. No improvement or deterioration (worsening of disease signs and symptoms compared to Baseline in the view of investigator/subject) comprise "not improved" status.
Time Frame At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (due to missing data number of participants differs from number at Baseline)
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description:
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).
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed 79 73
Measure Type: Number
Unit of Measure: Percentage of participants
Investigator 93.7 78.1
Participant 94.9 84.9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Hide Arm/Group Description 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). The participants of the placebo group received inert but identical-appearing, color-matched tablets.
All-Cause Mortality
EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)   0/86 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
EE20/Drospirenone (YAZ, BAY86-5300) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   34/87 (39.08%)   19/86 (22.09%) 
Gastrointestinal disorders     
Abdominal pain * 1  2/87 (2.30%)  0/86 (0.00%) 
Abdominal pain upper * 1  1/87 (1.15%)  0/86 (0.00%) 
Diarrhoea * 1  1/87 (1.15%)  0/86 (0.00%) 
Nausea * 1  1/87 (1.15%)  0/86 (0.00%) 
Toothache * 1  1/87 (1.15%)  0/86 (0.00%) 
Vomiting * 1  1/87 (1.15%)  0/86 (0.00%) 
General disorders     
Pyrexia * 1  1/87 (1.15%)  0/86 (0.00%) 
Infections and infestations     
Cervicitis * 1  1/87 (1.15%)  0/86 (0.00%) 
Nasopharyngitis * 1  4/87 (4.60%)  2/86 (2.33%) 
Pelvic inflammatory disease * 1  0/87 (0.00%)  1/86 (1.16%) 
Pneumonia * 1  0/87 (0.00%)  1/86 (1.16%) 
Papilloma viral infection * 1  0/87 (0.00%)  1/86 (1.16%) 
Investigations     
Blood cholesterol increased * 1  3/87 (3.45%)  1/86 (1.16%) 
Blood potassium decreased * 1  0/87 (0.00%)  1/86 (1.16%) 
Blood triglycerides increased * 1  1/87 (1.15%)  0/86 (0.00%) 
Glycosylated haemoglobin increased * 1  1/87 (1.15%)  0/86 (0.00%) 
Red blood cells urine positive * 1  0/87 (0.00%)  2/86 (2.33%) 
White blood cell count decreased * 1  0/87 (0.00%)  1/86 (1.16%) 
White blood cells urine positive * 1  1/87 (1.15%)  2/86 (2.33%) 
Metabolism and nutrition disorders     
Hyperlipidaemia * 1  1/87 (1.15%)  0/86 (0.00%) 
Nervous system disorders     
Dizziness * 1  0/87 (0.00%)  1/86 (1.16%) 
Reproductive system and breast disorders     
Breast mass * 1  2/87 (2.30%)  2/86 (2.33%) 
Breast pain * 1  1/87 (1.15%)  2/86 (2.33%) 
Cervical dysplasia * 1  0/87 (0.00%)  2/86 (2.33%) 
Fibrocystic breast disease * 1  1/87 (1.15%)  0/86 (0.00%) 
Hypomenorrhoea * 1  1/87 (1.15%)  0/86 (0.00%) 
Menorrhagia * 1  7/87 (8.05%)  0/86 (0.00%) 
Menstrual disorder * 1  1/87 (1.15%)  0/86 (0.00%) 
Menstruation delayed * 1  0/87 (0.00%)  1/86 (1.16%) 
Metrorrhagia * 1  7/87 (8.05%)  0/86 (0.00%) 
Oligomenorrhoea * 1  1/87 (1.15%)  0/86 (0.00%) 
Vaginal haemorrhage * 1  1/87 (1.15%)  0/86 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/87 (1.15%)  0/86 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne * 1  0/87 (0.00%)  3/86 (3.49%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00818519     History of Changes
Other Study ID Numbers: 91772
311963 ( Other Identifier: Company internal )
2014-004612-10 ( EudraCT Number )
First Submitted: January 6, 2009
First Posted: January 7, 2009
Results First Submitted: April 6, 2011
Results First Posted: June 9, 2011
Last Update Posted: August 25, 2015