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A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

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: NCT00630539
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Collaborators:
Hormos Medical
QuatRx Pharmaceuticals
Information provided by:
Shionogi Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Atrophy
Vaginal Diseases
Interventions Drug: Placebo
Drug: Ospemifene 5 mg
Drug: Ospemifene 15 mg
Drug: Ospemifene 30 mg
Enrollment 126

Recruitment Details The study was conducted at 9 centers in Finland. First patient was enrolled on August 09, 2007 and last patient completed on February 11, 2008
Pre-assignment Details The study population included postmenopausal women 40 to 80 years of age with a diagnosis of vulvar and vaginal atrophy (VVA) assessed by the maturation index (MI) of vaginal smear and vaginal pH at baseline
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Hide Arm/Group Description Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Period Title: Overall Study
Started 34 33 29 30
Completed 33 29 28 27
Not Completed 1 4 1 3
Reason Not Completed
Adverse Event             1             3             1             2
Withdrawal by Subject             0             1             0             1
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day Total
Hide Arm/Group Description Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 34 33 29 30 126
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 33 participants 29 participants 30 participants 126 participants
62.8  (6.0) 61.5  (5.6) 63.4  (7.1) 62.0  (6.8) 62.4  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 29 participants 30 participants 126 participants
Female
34
 100.0%
33
 100.0%
29
 100.0%
30
 100.0%
126
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Participants Number Analyzed 34 participants 33 participants 29 participants 30 participants 126 participants
34 33 29 30 126
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 34 participants 33 participants 29 participants 30 participants 126 participants
69.6  (10.1) 66.5  (10.6) 68.7  (13.5) 65.9  (7.4) 67.7  (10.4)
Height  
Mean (Standard Deviation)
Unit of measure:  m
Number Analyzed 34 participants 33 participants 29 participants 30 participants 126 participants
1.609  (0.049) 1.636  (.051) 1.641  (.062) 1.617  (.058) 1.626  (0.055)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 34 participants 33 participants 29 participants 30 participants 126 participants
26.89  (3.95) 24.78  (3.44) 25.50  (4.99) 25.28  (3.20) 25.61  (3.90)
Alcohol  
Mean (Standard Deviation)
Unit of measure:  Drinks/week
Number Analyzed 34 participants 33 participants 29 participants 30 participants 126 participants
0.9  (1.9) 1.8  (2.4) 1.2  (1.7) 1.5  (2.3) 1.4  (2.1)
1.Primary Outcome
Title Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
Hide Description [Not Specified]
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Hide Arm/Group Description:
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Overall Number of Participants Analyzed 34 33 29 30
Mean (Standard Deviation)
Unit of Measure: percentage of parabasal cells
-3.0  (30.2) -2.8  (33.2) -24.1  (36.7) -26.8  (41.1)
2.Primary Outcome
Title Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear
Hide Description [Not Specified]
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Hide Arm/Group Description:
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Overall Number of Participants Analyzed 34 33 29 30
Mean (Standard Deviation)
Unit of Measure: percentage of superficial cells
0.2  (1.5) 0.9  (3.1) 5.0  (9.1) 5.6  (10.3)
3.Primary Outcome
Title Mean Change From Baseline in Vaginal pH
Hide Description [Not Specified]
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Hide Arm/Group Description:
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Overall Number of Participants Analyzed 34 33 29 30
Mean (Standard Deviation)
Unit of Measure: pH
-0.07  (0.91) -0.37  (0.83) -0.95  (1.02) -1.11  (1.06)
4.Secondary Outcome
Title Visual Evaluation of Vagina (by Gynecological Examination)
Hide Description [Not Specified]
Time Frame Screening & Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo Subjects on Placebo (Week 12) Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 5 mg/Day (Week 12) Subjects on Ospemifene 15 mg/Day Subjects on Ospemifine 15 mg/Day (Week 12) Subjects on Ospemifene 30 mg/Day Subjects on Ospemifene 30 mg/Day (Week 12)
Hide Arm/Group Description:
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Overall Number of Participants Analyzed 34 34 33 33 29 29 30 30
Measure Type: Number
Unit of Measure: percentage of subjects
Petechiae-None 14.7 35.3 24.2 36.4 10.3 55.2 10.0 60.0
Petechiae-Mild 47.1 29.4 42.4 39.4 55.2 24.1 53.3 30.0
Petechiae-Moderate 26.5 26.5 12.1 6.1 31.0 17.2 26.7 3.3
Petechiae-Severe 11.8 8.8 21.2 15.2 3.4 0.0 10.0 3.3
Petechiae-Not done 0.0 0.0 0.0 3.0 0.0 3.4 0.0 0.0
Pallor-None 8.8 14.7 6.1 15.2 13.8 37.9 6.7 46.7
Pallor-Mild 44.1 47.1 30.3 48.5 48.3 48.3 40.0 43.3
Pallor-Moderate 41.2 35.3 57.6 30.3 31.0 10.3 43.3 6.7
Pallor-Severe 5.9 2.9 6.1 3.0 6.9 0.0 10.0 0.0
Pallor-Not done 0.0 0.0 0.0 3.0 0.0 3.4 0.0 0.0
Friability-None 8.8 20.6 15.2 30.3 10.3 44.8 16.7 60.0
Friability-Mild 41.2 32.4 27.3 30.3 34.5 44.8 40.0 33.3
Friability-Moderate 38.2 41.2 36.4 33.3 48.3 6.9 23.3 3.3
Friability-Severe 11.8 5.9 21.2 3.0 6.9 0.0 20.0 0.0
Friability-Not done 0.0 0.0 0.0 3.0 0.0 3.4 0.0 0.0
Vaginal dryness in the mucosa-None 8.8 23.5 6.1 27.3 10.3 51.7 10.0 73.3
Vaginal dryness in the mucosa-Mild 47.1 41.2 21.2 36.4 41.4 37.9 43.3 16.7
Vaginal dryness in the mucosa-Moderate 38.2 32.4 63.6 30.3 37.9 6.9 33.3 6.7
Vaginal dryness in the mucosa-Severe 5.9 2.9 9.1 3.0 10.3 0.0 13.3 0.0
Vaginal dryness in the mucosa-Not done 0.0 0.0 0.0 3.0 0.0 3.4 0.0 0.0
Vaginal redness in the mucosa-None 8.8 20.6 18.2 39.4 17.2 51.7 10.0 53.3
Vaginal redness in the mucosa-Mild 52.9 41.2 33.3 21.2 48.3 27.6 50.0 40.0
Vaginal redness in the mucosa-Moderate 26.5 26.5 33.3 21.2 31.0 17.2 23.3 0.0
Vaginal redness in the mucosa-Severe 11.8 11.8 15.2 15.2 3.4 0.0 16.7 3.3
Vaginal redness in the mucosa-Not done 0.0 0.0 0.0 3.0 0.0 3.4 0.0 0.0
5.Secondary Outcome
Title Mean Change From Baseline in Vaginal pH
Hide Description [Not Specified]
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Hide Arm/Group Description:
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Overall Number of Participants Analyzed 34 33 29 30
Mean (Standard Deviation)
Unit of Measure: pH
-0.12  (0.59) -0.26  (0.68) -0.53  (0.83) -0.78  (1.00)
6.Secondary Outcome
Title Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index
Hide Description [Not Specified]
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Hide Arm/Group Description:
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Overall Number of Participants Analyzed 34 33 29 30
Mean (Standard Deviation)
Unit of Measure: percentage of superficial cells
0.6  (2.7) 0.6  (2.9) 2.5  (5.6) 5.0  (10.7)
7.Secondary Outcome
Title Mean Change From Baseline in Estradiol Levels
Hide Description [Not Specified]
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Hide Arm/Group Description:
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Overall Number of Participants Analyzed 34 33 29 30
Mean (Standard Deviation)
Unit of Measure: nmol/L
-0.004  (0.011) 0.004  (0.015) -0.010  (0.026) -0.003  (0.008)
8.Secondary Outcome
Title Mean Change From Baseline in Luteinizing Hormone Levels
Hide Description [Not Specified]
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Hide Arm/Group Description:
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Overall Number of Participants Analyzed 34 33 29 30
Mean (Standard Deviation)
Unit of Measure: U/L
-1.36  (4.71) -2.89  (5.94) -0.34  (9.23) -3.78  (7.34)
9.Secondary Outcome
Title Mean Change From Baseline in Follicle Stimulating Hormone Levels
Hide Description [Not Specified]
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Hide Arm/Group Description:
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Overall Number of Participants Analyzed 34 33 29 30
Mean (Standard Deviation)
Unit of Measure: U/L
-10.36  (20.41) -7.04  (10.80) -5.99  (23.07) -15.32  (13.13)
10.Secondary Outcome
Title Mean Change From Baseline in Sex Hormone Binding Globulin Levels
Hide Description [Not Specified]
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Hide Arm/Group Description:
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Overall Number of Participants Analyzed 34 33 29 30
Mean (Standard Deviation)
Unit of Measure: nmol/L
-2.4  (10.0) 2.9  (12.2) 6.3  (12.5) 18.0  (20.2)
11.Secondary Outcome
Title Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index
Hide Description [Not Specified]
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Hide Arm/Group Description:
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Overall Number of Participants Analyzed 34 33 29 30
Mean (Standard Deviation)
Unit of Measure: percentage of parabasal cells
-0.6  (24.1) -0.6  (23.8) -19.7  (27.0) -22.0  (42.7)
Time Frame Throughout the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Hide Arm/Group Description Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
All-Cause Mortality
Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/34 (2.94%)   0/33 (0.00%)   0/29 (0.00%)   0/30 (0.00%) 
Injury, poisoning and procedural complications         
Ankle fracture  1  1/34 (2.94%)  0/33 (0.00%)  0/29 (0.00%)  0/30 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Subjects on Placebo Subjects on Ospemifene 5 mg/Day Subjects on Ospemifene 15 mg/Day Subjects on Ospemifene 30 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/34 (73.53%)   7/33 (21.21%)   13/29 (44.83%)   16/30 (53.33%) 
Infections and infestations         
Influenza  1  2/34 (5.88%)  0/33 (0.00%)  1/29 (3.45%)  2/30 (6.67%) 
Respiratory tract infection  1  2/34 (5.88%)  0/33 (0.00%)  0/29 (0.00%)  0/30 (0.00%) 
Urinary tract infection  1  2/34 (5.88%)  1/33 (3.03%)  0/29 (0.00%)  2/30 (6.67%) 
Vaginitis bacterial  1  2/34 (5.88%)  0/33 (0.00%)  0/29 (0.00%)  0/30 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  2/34 (5.88%)  2/33 (6.06%)  0/29 (0.00%)  1/30 (3.33%) 
Muscle spasms  1  1/34 (2.94%)  0/33 (0.00%)  0/29 (0.00%)  2/30 (6.67%) 
Pain in jaw  1  2/34 (5.88%)  0/33 (0.00%)  0/29 (0.00%)  0/30 (0.00%) 
Nervous system disorders         
Dizziness  1  2/34 (5.88%)  0/33 (0.00%)  0/29 (0.00%)  2/30 (6.67%) 
Headache  1  1/34 (2.94%)  1/33 (3.03%)  5/29 (17.24%)  1/30 (3.33%) 
Psychiatric disorders         
Insomnia  1  2/34 (5.88%)  0/33 (0.00%)  1/29 (3.45%)  0/30 (0.00%) 
Renal and urinary disorders         
Dysuria  1  2/34 (5.88%)  0/33 (0.00%)  0/29 (0.00%)  0/30 (0.00%) 
Reproductive system and breast disorders         
Genital discharge  1  1/34 (2.94%)  0/33 (0.00%)  2/29 (6.90%)  1/30 (3.33%) 
Postmenopausal haemorrhage  1  0/34 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  2/30 (6.67%) 
Vulvovaginal discomfort  1  2/34 (5.88%)  0/33 (0.00%)  1/29 (3.45%)  0/30 (0.00%) 
Vascular disorders         
Hot flush  1  2/34 (5.88%)  3/33 (9.09%)  3/29 (10.34%)  3/30 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
Results Point of Contact
Name/Title: Shionogi Clinical Trials Administrator
Organization: Shionogi Inc.
Phone: 800-849-9707 ext 1454
Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT00630539     History of Changes
Other Study ID Numbers: 15-50717
First Submitted: February 28, 2008
First Posted: March 7, 2008
Results First Submitted: March 19, 2013
Results First Posted: June 28, 2013
Last Update Posted: June 28, 2013