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Effects of SH T00658ID on Libido

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00764881
First received: October 1, 2008
Last updated: April 1, 2014
Last verified: April 2014
Results First Received: July 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Contraception
Libido
Interventions: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
Drug: Microgynon
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
The date of first subject was 29 Jan 2009. The date of last subject was 20 Jul 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 276 participants screened, 29 failed Screening, and 217 were randomized 1:1, of which 1 never received treatment, 3 had no observations, and 213 were treated (EV/DNG=106; EE/LNG=107).

Reporting Groups
  Description
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
EE/LNG (Microgynon) + Placebo Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.

Participant Flow:   Overall Study
    EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)     EE/LNG (Microgynon) + Placebo  
STARTED     108     109  
Subjects Received Treatment     106 [1]   107 [1]
COMPLETED     92     99  
NOT COMPLETED     16     10  
Adverse Event                 5                 1  
Withdrawal by Subject                 1                 3  
Protocol Violation                 2                 2  
Lost to Follow-up                 2                 0  
Noncompliant                 1                 0  
Accidentally discontinued study drug                 1                 0  
Wished to become pregnant                 1                 0  
Carcinoma detected                 1                 0  
Possibly noncompliant (study drug)                 0                 2  
no treatment or no observation                 2                 2  
[1] Full Analysis Set (FAS)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
EE/LNG (Microgynon) + Placebo Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Total Total of all reporting groups

Baseline Measures
    EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)     EE/LNG (Microgynon) + Placebo     Total  
Number of Participants  
[units: participants]
  106     107     213  
Age  
[units: years]
Mean ± Standard Deviation
  30.9  ± 7.0     30.2  ± 7.8     30.5  ± 7.4  
Gender  
[units: participants]
     
Female     106     107     213  
Male     0     0     0  
Ethnic group  
[units: participants]
     
Caucasian     90     92     182  
Hispanic     0     1     1  
Asian     16     13     29  
Other     0     1     1  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  22.8  ± 3.2     22.7  ± 2.9     22.8  ± 3.0  



  Outcome Measures
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1.  Primary:   Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) – Full Analysis Set (FAS)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

2.  Primary:   Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) – Per Protocol Set (PPS)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

3.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline   [ Time Frame: At Baseline ]

4.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

5.  Secondary:   Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

6.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline   [ Time Frame: At Baseline ]

7.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

8.  Secondary:   Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

9.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline   [ Time Frame: At Baseline ]

10.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

11.  Secondary:   Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

12.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline   [ Time Frame: At Baseline ]

13.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

14.  Secondary:   Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

15.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline   [ Time Frame: At Baseline ]

16.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

17.  Secondary:   Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

18.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.   [ Time Frame: At Baseline ]

19.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

20.  Secondary:   Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

21.  Secondary:   The Mean Absolute Values of FSFI Total Score at Baseline   [ Time Frame: At Baseline ]

22.  Secondary:   The Mean Absolute Values of FSFI Total Score at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

23.  Secondary:   Mean Change From Baseline to Cycle 6 in FSFI Total Score   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

24.  Secondary:   The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline   [ Time Frame: At Baseline ]

25.  Secondary:   The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

26.  Secondary:   Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

27.  Secondary:   The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline   [ Time Frame: At Baseline ]

28.  Secondary:   The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

29.  Secondary:   Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

30.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline   [ Time Frame: At Baseline ]

31.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

32.  Secondary:   Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

33.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Baseline   [ Time Frame: At Baseline ]

34.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

35.  Secondary:   Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Anxiety   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

36.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Baseline   [ Time Frame: At Baseline ]

37.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

38.  Secondary:   Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Depressed Mood   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

39.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Baseline   [ Time Frame: At Baseline ]

40.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

41.  Secondary:   Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Positive Well-being   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

42.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Baseline   [ Time Frame: At Baseline ]

43.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

44.  Secondary:   Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Self-control   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

45.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Baseline   [ Time Frame: At Baseline ]

46.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

47.  Secondary:   Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – General Health   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

48.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Baseline   [ Time Frame: At Baseline ]

49.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

50.  Secondary:   Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Vitality   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

51.  Secondary:   Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

52.  Secondary:   Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

53.  Secondary:   Vaginal Effects Evaluated by Vaginal pH at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

54.  Secondary:   Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline   [ Time Frame: At Baseline ]

55.  Secondary:   Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

56.  Secondary:   Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

57.  Secondary:   Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline   [ Time Frame: At Baseline ]

58.  Secondary:   Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

59.  Secondary:   Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

60.  Secondary:   Number of Bleeding / Spotting Days in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

61.  Secondary:   Number of Bleeding / Spotting Days in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

62.  Secondary:   Number of Bleeding / Spotting Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

63.  Secondary:   Number of Bleeding / Spotting Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

64.  Secondary:   Mean Length of Bleeding / Spotting Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

65.  Secondary:   Mean Length of Bleeding / Spotting Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

66.  Secondary:   Maximum Length of Bleeding / Spotting Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

67.  Secondary:   Maximum Length of Bleeding / Spotting Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

68.  Secondary:   Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

69.  Secondary:   Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

70.  Secondary:   Number of Spotting Only Days in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

71.  Secondary:   Number of Spotting Only Days in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

72.  Secondary:   Number of Spotting Only Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

73.  Secondary:   Number of Spotting Only Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

74.  Secondary:   Mean Length of Spotting-only Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

75.  Secondary:   Mean Length of Spotting-only Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

76.  Secondary:   Maximum Length of Spotting-only Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

77.  Secondary:   Maximum Length of Spotting-only Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

78.  Secondary:   Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

79.  Secondary:   Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

80.  Secondary:   Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

81.  Secondary:   Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

82.  Secondary:   Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

83.  Secondary:   Length of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

84.  Secondary:   Length of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

85.  Secondary:   Length of Withdrawal Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

86.  Secondary:   Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

87.  Secondary:   Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

88.  Secondary:   Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

89.  Secondary:   Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

90.  Secondary:   Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

91.  Secondary:   Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

92.  Secondary:   Onset of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1 ]

93.  Secondary:   Onset of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3 ]

94.  Secondary:   Onset of Withdrawal Bleeding Episodes at Cycle 6   [ Time Frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6 ]

95.  Secondary:   Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

96.  Secondary:   Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

97.  Secondary:   Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

98.  Secondary:   Number of Intracyclic Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

99.  Secondary:   Number of Intracyclic Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

100.  Secondary:   Number of Intracyclic Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

101.  Secondary:   Maximum Length of Intracyclic Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

102.  Secondary:   Maximum Length of Intracyclic Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

103.  Secondary:   Maximum Length of Intracyclic Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

104.  Secondary:   Number of Intracyclic Bleeding Days at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

105.  Secondary:   Number of Intracyclic Bleeding Days at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

106.  Secondary:   Number of Intracyclic Bleeding Days at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

107.  Secondary:   Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

108.  Secondary:   Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

109.  Secondary:   Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

110.  Secondary:   Percentage of Participants With at Least 1 Intracyclic Bleeding Episode   [ Time Frame: Up to Cycle 6 (28 days per Cycle) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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


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Publications automatically indexed to this study:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00764881     History of Changes
Other Study ID Numbers: 91548, 2008-002263-13, 310785
Study First Received: October 1, 2008
Results First Received: July 28, 2011
Last Updated: April 1, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Spain: Spanish Agency of Medicines
Thailand: Food and Drug Administration