Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 61 of 89 for:    DESVENLAFAXINE

The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms

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: NCT00401245
Recruitment Status : Completed
First Posted : November 20, 2006
Results First Posted : October 12, 2011
Last Update Posted : October 26, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Vasomotor Symptoms
Interventions Drug: desvenlafaxine succinate sustained release
Drug: Placebo
Enrollment 500
Recruitment Details  
Pre-assignment Details A total of 500 participants were randomized to the study, of which 7 were not treated due to other unspecified reasons. A second randomization occurred for the taper phase.
Arm/Group Title DVS 25 mg, Then 100 mg DVS 25/50 mg, Then 100 mg DVS 50 mg, Then 100 mg DVS 100 mg, Then 100 mg DVS 50 mg QOD DVS 50/25 mg DVS 50 mg/Placebo Placebo
Hide Arm/Group Description Desvenlafaxine succinate (DVS) 25 milligram (mg) tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week open label (OL) phase. DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase. DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase. DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase. Re-randomized to DVS 50 mg tablet taken orally every other day (QOD) alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase). Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase). Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase). Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
Period Title: Double Blind Titration Phase
Started 126 121 124 122 0 0 0 0
Completed 122 118 118 107 0 0 0 0
Not Completed 4 3 6 15 0 0 0 0
Reason Not Completed
Adverse Event             3             2             5             12             0             0             0             0
Other             0             0             1             0             0             0             0             0
Protocol Violation             0             0             0             1             0             0             0             0
Withdrawal by Subject             1             1             0             2             0             0             0             0
Period Title: Between Titration and Open Label Phase
Started 122 118 118 107 0 0 0 0
Completed 122 116 118 105 0 0 0 0
Not Completed 0 2 0 2 0 0 0 0
Reason Not Completed
Did not enter the open label phase             0             2             0             2             0             0             0             0
Period Title: Open Label Phase
Started 122 116 118 105 0 0 0 0
Completed 101 81 95 84 0 0 0 0
Not Completed 21 35 23 21 0 0 0 0
Reason Not Completed
Adverse Event             5             14             6             7             0             0             0             0
Lost to Follow-up             5             7             5             4             0             0             0             0
Other             4             8             7             8             0             0             0             0
Protocol Violation             0             1             0             1             0             0             0             0
Withdrawal by Subject             3             3             2             1             0             0             0             0
Lack of Efficacy             4             2             3             0             0             0             0             0
Period Title: Double Blind Tapering Phase
Started 0 0 0 0 101 94 87 102
Completed 0 0 0 0 97 90 80 95
Not Completed 0 0 0 0 4 4 7 7
Reason Not Completed
Adverse Event             0             0             0             0             1             1             2             4
Investigator request             0             0             0             0             0             0             0             1
Other             0             0             0             0             1             0             2             2
Withdrawal by Subject             0             0             0             0             2             2             3             0
Lack of Efficacy             0             0             0             0             0             1             0             0
Arm/Group Title DVS 25 mg, Then 100 mg DVS 25/50 mg, Then 100 mg DVS 50 mg, Then 100 mg DVS 100 mg, Then 100 mg Total
Hide Arm/Group Description DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase. DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase. DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase. DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase. Total of all reporting groups
Overall Number of Baseline Participants 126 121 124 122 493
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants 121 participants 124 participants 122 participants 493 participants
54.52  (5.01) 54.40  (6.37) 53.98  (5.16) 53.48  (5.27) 54.10  (5.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 121 participants 124 participants 122 participants 493 participants
Female
126
 100.0%
121
 100.0%
124
 100.0%
122
 100.0%
493
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Nausea During the First 2 Weeks of Treatment
Hide Description Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.
Time Frame Baseline up to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.
Arm/Group Title DVS 25 mg, Then 100 mg DVS 25/50 mg, Then 100 mg DVS 50 mg, Then 100 mg DVS 100 mg, Then 100 mg
Hide Arm/Group Description:
DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
Overall Number of Participants Analyzed 126 121 124 122
Measure Type: Number
Unit of Measure: Participants
24 31 28 43
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS 25 mg, Then 100 mg, DVS 25/50 mg, Then 100 mg, DVS 50 mg, Then 100 mg, DVS 100 mg, Then 100 mg
Comments Overall comparison was made between each titration regimen and the control regimen (100 mg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering
Hide Description DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Time Frame Week 17
Hide Outcome Measure Data
Hide Analysis Population Description
The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.
Arm/Group Title DVS 50 mg QOD DVS 50/25 mg DVS 50 mg/Placebo Placebo
Hide Arm/Group Description:
Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
Overall Number of Participants Analyzed 100 86 83 98
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.26  (3.46) 2.28  (3.59) 1.84  (3.36) 7.07  (7.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS 50 mg QOD, Placebo
Comments For DVS 50 mg QOD, analysis of variance (ANOVA) was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DVS 50/25 mg, Placebo
Comments For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DVS 50 mg/Placebo, Placebo
Comments For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title DESS Total Score at End of Second Week of Tapering
Hide Description DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.
Arm/Group Title DVS 50 mg QOD DVS 50/25 mg DVS 50 mg/Placebo Placebo
Hide Arm/Group Description:
Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
Overall Number of Participants Analyzed 89 87 79 91
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.19  (1.96) 2.44  (5.53) 4.46  (6.44) 2.44  (4.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS 50 mg QOD, Placebo
Comments For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DVS 50/25 mg, Placebo
Comments For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.997
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DVS 50 mg/Placebo, Placebo
Comments For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title DESS Total Score at 1 Week After the End of Tapering
Hide Description DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.
Arm/Group Title DVS 50 mg QOD DVS 50/25 mg DVS 50 mg/Placebo Placebo
Hide Arm/Group Description:
Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
Overall Number of Participants Analyzed 59 57 47 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.22  (4.82) 4.11  (5.77) 1.70  (3.16) 1.78  (3.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS 50 mg QOD, Placebo
Comments For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DVS 50/25 mg, Placebo
Comments For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DVS 50 mg/Placebo, Placebo
Comments For DVS 50mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.929
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment
Hide Description Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
Time Frame Baseline up to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.
Arm/Group Title DVS 25 mg, Then 100 mg DVS 25/50 mg, Then 100 mg DVS 50 mg, Then 100 mg DVS 100 mg, Then 100 mg
Hide Arm/Group Description:
DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
Overall Number of Participants Analyzed 126 121 124 122
Measure Type: Number
Unit of Measure: Participants
67 69 72 80
6.Secondary Outcome
Title Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment
Hide Description Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
Time Frame Baseline up to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.
Arm/Group Title DVS 25 mg, Then 100 mg DVS 25/50 mg, Then 100 mg DVS 50 mg, Then 100 mg DVS 100 mg, Then 100 mg
Hide Arm/Group Description:
DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
Overall Number of Participants Analyzed 126 121 124 122
Measure Type: Number
Unit of Measure: Percentage of participants
4.0 9.1 6.5 14.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS 25 mg, Then 100 mg, DVS 25/50 mg, Then 100 mg, DVS 50 mg, Then 100 mg, DVS 100 mg, Then 100 mg
Comments Overall comparison was made between each titration regimen and the control regimen (100 mg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Each DESS at the End of First Week of Tapering
Hide Description DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Time Frame Week 17
Hide Outcome Measure Data
Hide Analysis Population Description
The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.
Arm/Group Title DVS 50 mg QOD DVS 50/25 mg DVS 50 mg/Placebo Placebo
Hide Arm/Group Description:
Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
Overall Number of Participants Analyzed 101 94 87 102
Measure Type: Number
Unit of Measure: Participants
Agitation 1 7 6 18
Blurred vision 4 4 2 13
Bouts of crying or tearfulness 5 3 6 24
Burning, numbness, tingling sensations 5 3 3 9
Chills 3 2 3 9
Confusion or trouble concentrating 5 4 2 21
Diarrhea 7 3 4 20
Dizziness, lightheadedness, sensation of spinning 18 7 9 41
Elevated mood, feeling high 1 0 0 13
Fatigue, tiredness 9 11 6 24
Feeling unreal or detached 6 2 1 20
Fever 2 0 1 4
Forgetfulness or problems with memory 6 6 3 12
Headaches 8 5 9 28
Increased dreaming or nightmares 14 13 12 35
Increased saliva in mouth 0 0 0 4
Irritability 6 6 6 26
Mood swings 4 5 4 19
Muscle aches or pains 5 8 3 19
Muscle cramps, spasms, or twitching 5 6 2 12
Muscle tension or stiffness 6 6 7 18
Nausea 14 7 5 28
Nervousness or anxiety 2 5 7 19
Nose running 3 3 3 7
Problems with speech or speaking clearly 3 2 0 6
Restless feeling in legs 5 4 0 4
Ringing or noises in the ears 6 2 6 14
Shaking, trembling 4 4 2 11
Shortness of breath, gasping for air 1 3 1 6
Sore eyes 3 3 5 8
Stomach bloating 5 6 5 19
Stomach cramps 6 4 0 11
Sudden outbursts of anger 3 4 2 11
Sudden panic or anxiety attacks 0 2 0 9
Sudden worsening of mood 3 6 4 22
Sweating more than usual 23 19 14 44
Trouble sleeping, insomnia 13 11 8 37
Uncontrolled mouth/tongue movements 1 1 0 0
Unsteady gait or incoordination 4 1 0 16
Unusual sensitivity to sound 1 5 1 7
Unusual tastes or smells 1 2 1 4
Unusual visual sensations 1 0 0 10
Vomiting 4 1 0 11
8.Secondary Outcome
Title Number of Participants With Each DESS at the End of Second Week of Tapering
Hide Description DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.
Arm/Group Title DVS 50 mg QOD DVS 50/25 mg DVS 50 mg/Placebo Placebo
Hide Arm/Group Description:
Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
Overall Number of Participants Analyzed 89 87 79 91
Measure Type: Number
Unit of Measure: Participants
Agitation 6 4 10 9
Blurred vision 2 6 7 3
Bouts of crying or tearfulness 2 5 18 6
Burning, numbness, tingling sensations 0 2 3 4
Chills 1 3 8 4
Confusion or trouble concentrating 0 7 11 4
Diarrhea 2 2 5 1
Dizziness, lightheadedness, sensation of spinning 2 12 21 7
Elevated mood, feeling high 3 3 5 3
Fatigue, tiredness 3 12 14 11
Feeling unreal or detached 0 5 9 3
Fever 0 0 1 1
Forgetfulness or problems with memory 1 6 4 2
Headaches 4 5 8 4
Increased dreaming or nightmares 4 5 10 8
Increased saliva in mouth 1 1 2 4
Irritability 5 10 18 13
Mood swings 3 7 14 5
Muscle aches or pains 2 8 9 7
Muscle cramps, spasms, or twitching 7 3 6 5
Muscle tension or stiffness 1 8 7 7
Nausea 3 6 15 4
Nervousness or anxiety 4 6 12 8
Nose running 1 5 4 7
Problems with speech or speaking clearly 0 3 4 1
Restless feeling in legs 4 4 4 4
Ringing or noises in the ears 1 4 6 2
Shaking, trembling 1 3 3 3
Shortness of breath, gasping for air 0 2 1 4
Sore eyes 2 4 3 5
Stomach bloating 1 5 6 5
Stomach cramps 2 3 4 0
Sudden outbursts of anger 4 5 12 8
Sudden panic or anxiety attacks 0 3 5 1
Sudden worsening of mood 6 5 18 8
Sweating more than usual 19 17 23 23
Trouble sleeping, insomnia 8 9 22 19
Uncontrolled mouth/tongue movements 0 1 0 1
Unsteady gait or incoordination 0 7 5 3
Unusual sensitivity to sound 0 5 3 2
Unusual tastes or smells 1 1 4 1
Unusual visual sensations 0 0 3 2
Vomiting 0 0 5 0
9.Secondary Outcome
Title Number of Participants With Each DESS One Week After End of Tapering
Hide Description DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.
Arm/Group Title DVS 50 mg QOD DVS 50/25 mg DVS 50 mg/Placebo Placebo
Hide Arm/Group Description:
Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
Overall Number of Participants Analyzed 59 57 47 59
Measure Type: Number
Unit of Measure: Participants
Agitation 6 4 6 5
Blurred vision 2 0 0 1
Bouts of crying or tearfulness 7 7 2 3
Burning, numbness, tingling sensations 2 9 0 2
Chills 3 3 1 3
Confusion or trouble concentrating 6 7 4 2
Diarrhea 3 3 1 1
Dizziness, lightheadedness, sensation of spinning 13 17 2 0
Elevated mood, feeling high 1 2 0 0
Fatigue, tiredness 9 10 2 8
Feeling unreal or detached 6 5 1 3
Fever 2 0 0 0
Forgetfulness or problems with memory 5 3 2 3
Headaches 4 11 3 5
Increased dreaming or nightmares 7 10 0 3
Increased saliva in mouth 0 1 1 1
Irritability 11 9 7 6
Mood swings 4 5 6 4
Muscle aches or pains 5 8 5 3
Muscle cramps, spasms, or twitching 5 5 1 1
Muscle tension or stiffness 5 9 3 2
Nausea 5 5 0 1
Nervousness or anxiety 9 10 5 3
Nose running 1 2 3 1
Problems with speech or speaking clearly 0 2 0 0
Restless feeling in legs 1 6 3 1
Ringing or noises in the ears 3 8 0 0
Shaking, trembling 3 3 0 1
Shortness of breath, gasping for air 1 1 1 0
Sore eyes 3 4 1 2
Stomach bloating 3 4 1 4
Stomach cramps 2 3 0 2
Sudden outbursts of anger 4 3 3 5
Sudden panic or anxiety attacks 1 5 2 2
Sudden worsening of mood 7 4 5 5
Sweating more than usual 21 19 4 12
Trouble sleeping, insomnia 12 13 5 7
Uncontrolled mouth/tongue movements 0 1 0 0
Unsteady gait or incoordination 4 5 0 1
Unusual sensitivity to sound 1 2 0 1
Unusual tastes or smells 1 3 0 0
Unusual visual sensations 0 3 0 1
Vomiting 1 0 0 0
10.Secondary Outcome
Title Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment
Hide Description Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants’ response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.
Time Frame Week 1 and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.
Arm/Group Title DVS 25 mg, Then 100 mg DVS 25/50 mg, Then 100 mg DVS 50 mg, Then 100 mg DVS 100 mg, Then 100 mg
Hide Arm/Group Description:
DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
Overall Number of Participants Analyzed 126 121 124 122
Measure Type: Number
Unit of Measure: Participants
Week 1: Extremely dissatisfied (n=124,119,120,111) 2 3 1 4
Week 1: Dissatisfied (n=124,119,120,111) 1 6 8 16
Week 1: Neutral (n=124,119,120,111) 20 13 28 19
Week 1: Satisfied (n=124,119,120,111) 47 48 43 39
Week 1: Extremely satisfied (n=124,119,120,111) 54 49 40 33
Week 2: Extremely dissatisfied (n=115,105,113,94) 2 0 0 0
Week 2: Dissatisfied (n=115,105,113,94) 3 4 8 1
Week 2: Neutral (n=115,105,113,94) 17 17 18 15
Week 2: Satisfied (n=115,105,113,94) 43 35 41 40
Week 2: Extremely satisfied (n=115,105,113,94) 50 49 46 38
11.Secondary Outcome
Title Number of Participants Showing Satisfaction With Tolerability at the End of Tapering
Hide Description Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants’ response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.
Arm/Group Title DVS 50 mg QOD DVS 50/25 mg DVS 50 mg/Placebo Placebo
Hide Arm/Group Description:
Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
Overall Number of Participants Analyzed 53 52 40 55
Measure Type: Number
Unit of Measure: Participants
Extremely dissatisfied 7 5 3 6
Dissatisfied 10 7 3 5
Neutral 10 5 5 7
Satisfied 16 23 19 19
Extremely satisfied 10 12 10 18
12.Secondary Outcome
Title Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score
Hide Description MS-TSQ is a questionnaire assessing participants’ degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The OL population included all participants who had taken at least 1 dose of open label test article. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.
Arm/Group Title DVS 100 mg
Hide Arm/Group Description:
DVS 100 mg tablet taken orally daily for 15 weeks (OL phase).
Overall Number of Participants Analyzed 270
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Ability to control hot flushes during the day 2.64  (1.19)
Ability to control hot flushes during the night 2.71  (1.26)
Effect on quality of sleep 2.59  (1.18)
Effect on mood or emotions 3.02  (0.86)
Effect on interest in sex 2.37  (1.00)
Effect on ability to concentrate 2.67  (0.84)
Tolerability to side effects 3.04  (0.94)
Overall satisfaction 2.81  (1.10)
13.Secondary Outcome
Title Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16
Hide Description MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life.
Time Frame Baseline, Week 4, Week 8, Week 12 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The OL population included all participants who had taken at least 1 dose of open label test article. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.
Arm/Group Title DVS 100 mg
Hide Arm/Group Description:
DVS 100 mg tablet taken orally daily for 15 weeks (OL phase).
Overall Number of Participants Analyzed 406
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 4.46  (1.20)
Week 4 (n=385) 2.99  (1.09)
Week 8 (n=364) 2.85  (1.08)
Week 12 (n=354) 2.76  (1.06)
Week 16 (n=277) 2.67  (1.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS 100 mg
Comments Comparison was made between the difference in the means from the baseline value and post-baseline (Week 4) value with 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DVS 100 mg
Comments Comparison was made between the difference in the means from the baseline value and post-baseline (Week 8) value with 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DVS 100 mg
Comments Comparison was made between the difference in the means from the base value and post-baseline (Week 12) value with 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DVS 100 mg
Comments Comparison was made between the difference in the means from the baseline value and post-baseline (Week 16) value with 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
14.Other Pre-specified Outcome
Title Mean Age of the Participants in Tapering Phase
Hide Description Participants were re-randomized to tapering phase after OL phase.
Time Frame Week 17
Hide Outcome Measure Data
Hide Analysis Population Description
The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.
Arm/Group Title DVS 50 mg QOD DVS 50/25 mg DVS 50 mg/Placebo Placebo
Hide Arm/Group Description:
Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
Overall Number of Participants Analyzed 101 94 87 102
Mean (Standard Deviation)
Unit of Measure: Years
53.72  (5.02) 54.56  (5.21) 54.20  (6.31) 54.14  (5.09)
15.Other Pre-specified Outcome
Title Gender of the Participants in Tapering Phase
Hide Description Participants were re-randomized to tapering phase after OL phase.
Time Frame Week 17
Hide Outcome Measure Data
Hide Analysis Population Description
The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.
Arm/Group Title DVS 50 mg QOD DVS 50/25 mg DVS 50 mg/Placebo Placebo
Hide Arm/Group Description:
Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
Overall Number of Participants Analyzed 101 94 87 102
Measure Type: Number
Unit of Measure: Participants
Female 101 94 87 102
Male 0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title DVS 25 mg (Titration Phase) DVS 25/50 mg (Titration Phase) DVS 50 mg (Titration Phase) DVS 100 mg (Titration Phase) DVS 100 mg (OL Phase) DVS 50 mg QOD (Tapering Phase) DVS 50/25 mg (Tapering Phase) DVS 50 mg/Placebo (Tapering Phase) Placebo (Tapering Phase)
Hide Arm/Group Description DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase). DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase). DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase). DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase). After 1 week of double blind titration phase, DVS 100 mg tablet taken orally daily for 15 weeks. Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase). Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase). Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase). Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
All-Cause Mortality
DVS 25 mg (Titration Phase) DVS 25/50 mg (Titration Phase) DVS 50 mg (Titration Phase) DVS 100 mg (Titration Phase) DVS 100 mg (OL Phase) DVS 50 mg QOD (Tapering Phase) DVS 50/25 mg (Tapering Phase) DVS 50 mg/Placebo (Tapering Phase) Placebo (Tapering Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DVS 25 mg (Titration Phase) DVS 25/50 mg (Titration Phase) DVS 50 mg (Titration Phase) DVS 100 mg (Titration Phase) DVS 100 mg (OL Phase) DVS 50 mg QOD (Tapering Phase) DVS 50/25 mg (Tapering Phase) DVS 50 mg/Placebo (Tapering Phase) Placebo (Tapering Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/126 (0.00%)      0/121 (0.00%)      0/124 (0.00%)      0/122 (0.00%)      3/461 (0.65%)      0/101 (0.00%)      0/94 (0.00%)      0/87 (0.00%)      1/102 (0.98%)    
Cardiac disorders                   
Pericarditis * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  1/461 (0.22%)  0/101 (0.00%)  0/94 (0.00%)  0/87 (0.00%)  0/102 (0.00%) 
Supraventricular tachycardia * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  0/94 (0.00%)  0/87 (0.00%)  1/102 (0.98%) 
General disorders                   
Chest pain * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  1/461 (0.22%)  0/101 (0.00%)  0/94 (0.00%)  0/87 (0.00%)  0/102 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Pneumonia * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  1/461 (0.22%)  0/101 (0.00%)  0/94 (0.00%)  0/87 (0.00%)  0/102 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, COSTART
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
DVS 25 mg (Titration Phase) DVS 25/50 mg (Titration Phase) DVS 50 mg (Titration Phase) DVS 100 mg (Titration Phase) DVS 100 mg (OL Phase) DVS 50 mg QOD (Tapering Phase) DVS 50/25 mg (Tapering Phase) DVS 50 mg/Placebo (Tapering Phase) Placebo (Tapering Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/126 (39.68%)      55/121 (45.45%)      57/124 (45.97%)      73/122 (59.84%)      340/461 (73.75%)      74/101 (73.27%)      64/94 (68.09%)      67/87 (77.01%)      79/102 (77.45%)    
Blood and lymphatic system disorders                   
Anemia * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  2/101 (1.98%)  2/94 (2.13%)  0/87 (0.00%)  0/102 (0.00%) 
Echymosis * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  2/94 (2.13%)  2/87 (2.30%)  0/102 (0.00%) 
Cardiac disorders                   
Palpitation * 1  1/126 (0.79%)  1/121 (0.83%)  1/124 (0.81%)  3/122 (2.46%)  0/461 (0.00%)  0/101 (0.00%)  0/94 (0.00%)  0/87 (0.00%)  4/102 (3.92%) 
Ear and labyrinth disorders                   
Tinnitus * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  13/461 (2.82%)  3/101 (2.97%)  4/94 (4.26%)  3/87 (3.45%)  6/102 (5.88%) 
Eye disorders                   
Abnormal vision * 1  1/126 (0.79%)  1/121 (0.83%)  2/124 (1.61%)  4/122 (3.28%)  20/461 (4.34%)  3/101 (2.97%)  6/94 (6.38%)  5/87 (5.75%)  6/102 (5.88%) 
Eye pain * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  3/101 (2.97%)  2/94 (2.13%)  3/87 (3.45%)  3/102 (2.94%) 
Gastrointestinal disorders                   
Abdominal pain * 1  1/126 (0.79%)  4/121 (3.31%)  1/124 (0.81%)  2/122 (1.64%)  20/461 (4.34%)  6/101 (5.94%)  3/94 (3.19%)  1/87 (1.15%)  5/102 (4.90%) 
Abdominal distension * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  26/461 (5.64%)  7/101 (6.93%)  8/94 (8.51%)  5/87 (5.75%)  6/102 (5.88%) 
Anorexia * 1  1/126 (0.79%)  2/121 (1.65%)  5/124 (4.03%)  4/122 (3.28%)  16/461 (3.47%)  1/101 (0.99%)  1/94 (1.06%)  2/87 (2.30%)  0/102 (0.00%) 
Constipation * 1  2/126 (1.59%)  5/121 (4.13%)  4/124 (3.23%)  7/122 (5.74%)  42/461 (9.11%)  6/101 (5.94%)  5/94 (5.32%)  4/87 (4.60%)  5/102 (4.90%) 
Diarrhea * 1  3/126 (2.38%)  4/121 (3.31%)  1/124 (0.81%)  1/122 (0.82%)  24/461 (5.21%)  6/101 (5.94%)  4/94 (4.26%)  5/87 (5.75%)  10/102 (9.80%) 
Dry mouth * 1  4/126 (3.17%)  9/121 (7.44%)  11/124 (8.87%)  18/122 (14.75%)  44/461 (9.54%)  6/101 (5.94%)  4/94 (4.26%)  3/87 (3.45%)  4/102 (3.92%) 
Dyspepsia * 1  4/126 (3.17%)  2/121 (1.65%)  3/124 (2.42%)  5/122 (4.10%)  19/461 (4.12%)  3/101 (2.97%)  3/94 (3.19%)  2/87 (2.30%)  3/102 (2.94%) 
Flatulence * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  1/101 (0.99%)  2/94 (2.13%)  0/87 (0.00%)  3/102 (2.94%) 
Gastroesophageal reflux disease * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  2/94 (2.13%)  0/87 (0.00%)  1/102 (0.98%) 
Increased appetite * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  1/101 (0.99%)  2/94 (2.13%)  1/87 (1.15%)  1/102 (0.98%) 
Increased salivation * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  1/101 (0.99%)  0/94 (0.00%)  2/87 (2.30%)  1/102 (0.98%) 
Nausea * 1  19/126 (15.08%)  26/121 (21.49%)  26/124 (20.97%)  41/122 (33.61%)  91/461 (19.74%)  14/101 (13.86%)  13/94 (13.83%)  8/87 (9.20%)  12/102 (11.76%) 
Vomiting * 1  1/126 (0.79%)  1/121 (0.83%)  3/124 (2.42%)  4/122 (3.28%)  0/461 (0.00%)  5/101 (4.95%)  1/94 (1.06%)  2/87 (2.30%)  4/102 (3.92%) 
General disorders                   
Asthenia * 1  6/126 (4.76%)  4/121 (3.31%)  12/121 (9.92%)  11/122 (9.02%)  55/461 (11.93%)  14/101 (13.86%)  5/94 (5.32%)  5/87 (5.75%)  10/102 (9.80%) 
Chills * 1  1/126 (0.79%)  0/121 (0.00%)  2/124 (1.61%)  5/122 (4.10%)  0/461 (0.00%)  0/101 (0.00%)  3/94 (3.19%)  2/87 (2.30%)  4/102 (3.92%)  102
Cyst * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  1/101 (0.99%)  2/94 (2.13%)  1/87 (1.15%)  1/102 (0.98%) 
Fever * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  0/94 (0.00%)  3/87 (3.45%)  1/102 (0.98%) 
Flu syndrome * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  13/461 (2.82%)  0/101 (0.00%)  0/94 (0.00%)  0/87 (0.00%)  0/102 (0.00%) 
Reaction unevaluable * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  2/94 (2.13%)  0/87 (0.00%)  0/102 (0.00%) 
Infections and infestations                   
Infection * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  23/461 (4.99%)  2/101 (1.98%)  3/94 (3.19%)  3/87 (3.45%)  8/102 (7.84%) 
Injury, poisoning and procedural complications                   
Accidental injury * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  18/461 (3.90%)  2/101 (1.98%)  2/94 (2.13%)  3/87 (3.45%)  5/102 (4.90%) 
Metabolism and nutrition disorders                   
Hypercholesteremia * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  3/101 (2.97%)  3/94 (3.19%)  1/87 (1.15%)  3/102 (2.94%) 
Hyperlipemia * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  2/94 (2.13%)  0/87 (0.00%)  2/102 (1.96%) 
Musculoskeletal and connective tissue disorders                   
Back pain * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  24/461 (5.21%)  1/101 (0.99%)  3/94 (3.19%)  4/87 (4.60%)  2/102 (1.96%) 
Neck pain * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  10/461 (2.17%)  2/101 (1.98%)  3/94 (3.19%)  3/87 (3.45%)  2/102 (1.96%) 
Pain * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  20/461 (4.34%)  4/101 (3.96%)  5/94 (5.32%)  1/87 (1.15%)  4/102 (3.92%) 
Arthralgia * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  21/461 (4.56%)  1/101 (0.99%)  4/94 (4.26%)  5/87 (5.75%)  5/102 (4.90%) 
Arthritis * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  1/101 (0.99%)  0/94 (0.00%)  0/87 (0.00%)  3/102 (2.94%) 
Leg cramps * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  1/101 (0.99%)  2/94 (2.13%)  1/87 (1.15%)  1/102 (0.98%) 
Muscle cramp * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  3/101 (2.97%)  1/94 (1.06%)  1/87 (1.15%)  4/102 (3.92%) 
Muscle spasms * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  3/101 (2.97%)  1/94 (1.06%)  0/87 (0.00%)  1/102 (0.98%) 
Musculoskeletal stiffness * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  19/461 (4.12%)  4/101 (3.96%)  3/94 (3.19%)  4/87 (4.60%)  4/102 (3.92%) 
Myalgia * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  24/461 (5.21%)  7/101 (6.93%)  5/94 (5.32%)  1/87 (1.15%)  7/102 (6.86%) 
Nervous system disorders                   
Headache * 1  15/126 (11.90%)  12/121 (9.92%)  14/124 (11.29%)  14/122 (11.48%)  77/461 (16.70%)  12/101 (11.88%)  9/94 (9.57%)  11/87 (12.64%)  19/102 (18.63%) 
Migraine * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  1/94 (1.06%)  0/87 (0.00%)  3/102 (2.94%) 
Abnormal dreams * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  45/461 (9.76%)  11/101 (10.89%)  15/94 (15.96%)  10/87 (11.49%)  15/102 (14.71%) 
Agitation * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  1/101 (0.99%)  3/94 (3.19%)  2/87 (2.30%)  4/102 (3.92%) 
Anxiety * 1  2/126 (1.59%)  4/121 (3.31%)  1/124 (0.81%)  0/122 (0.00%)  17/461 (3.69%)  1/101 (0.99%)  5/94 (5.32%)  3/87 (3.45%)  7/102 (6.86%) 
Confusion * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  1/101 (0.99%)  1/94 (1.06%)  1/87 (1.15%)  3/102 (2.94%) 
Depersonalization * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  2/101 (1.98%)  3/94 (3.19%)  1/87 (1.15%)  5/102 (4.90%) 
Dizziness * 1  2/126 (1.59%)  6/121 (4.96%)  5/124 (4.03%)  11/122 (9.02%)  45/461 (9.76%)  16/101 (15.84%)  16/94 (17.02%)  13/87 (14.94%)  16/102 (15.69%) 
Emotional lability * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  12/461 (2.60%)  4/101 (3.96%)  2/94 (2.13%)  5/87 (5.75%)  10/102 (9.80%) 
Euphoria * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  0/94 (0.00%)  1/87 (1.15%)  4/102 (3.92%) 
Hostility * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  13/461 (2.82%)  2/101 (1.98%)  2/94 (2.13%)  3/87 (3.45%)  4/102 (3.92%) 
Hypesthesia * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  10/461 (2.17%)  0/101 (0.00%)  2/94 (2.13%)  2/87 (2.30%)  3/102 (2.94%) 
Incoordination * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  1/101 (0.99%)  2/94 (2.13%)  0/87 (0.00%)  6/102 (5.88%) 
Insonmnia * 1  3/126 (2.38%)  7/121 (5.79%)  7/124 (5.65%)  6/122 (4.92%)  62/461 (13.45%)  14/101 (13.86%)  10/94 (10.64%)  8/87 (9.20%)  13/102 (12.75%) 
Libido decreased * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  2/101 (1.98%)  2/94 (2.13%)  0/87 (0.00%)  0/102 (0.00%) 
Memory impairement * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  17/461 (3.69%)  6/101 (5.94%)  0/94 (0.00%)  4/87 (4.60%)  3/102 (2.94%) 
Nervousness * 1  2/126 (1.59%)  3/121 (2.48%)  0/124 (0.00%)  2/122 (1.64%)  12/461 (2.60%)  1/101 (0.99%)  2/94 (2.13%)  3/87 (3.45%)  3/102 (2.94%) 
Paresthesia * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  19/461 (4.12%)  2/101 (1.98%)  4/94 (4.26%)  4/87 (4.60%)  4/102 (3.92%) 
Restless legs syndrome * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  19/461 (4.12%)  5/101 (4.95%)  8/94 (8.51%)  2/87 (2.30%)  5/102 (4.90%) 
Somnolence * 1  0/126 (0.00%)  2/121 (1.65%)  7/124 (5.65%)  15/122 (12.30%)  31/461 (6.72%)  2/101 (1.98%)  2/94 (2.13%)  3/87 (3.45%)  4/102 (3.92%) 
Speech disorder * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  2/101 (1.98%)  2/94 (2.13%)  1/87 (1.15%)  1/102 (0.98%) 
Thinking abnormal * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  5/101 (4.95%)  1/94 (1.06%)  0/87 (0.00%)  0/102 (0.00%) 
Tremor * 1  1/126 (0.79%)  2/121 (1.65%)  3/124 (2.42%)  3/122 (2.46%)  14/461 (3.04%)  3/101 (2.97%)  3/94 (3.19%)  1/87 (1.15%)  3/102 (2.94%) 
Vertigo * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  3/122 (2.46%)  0/461 (0.00%)  2/101 (1.98%)  3/94 (3.19%)  2/87 (2.30%)  3/102 (2.94%) 
Parosmia * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  3/94 (3.19%)  0/87 (0.00%)  0/102 (0.00%) 
Taste perversion * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  16/461 (3.47%)  2/101 (1.98%)  4/94 (4.26%)  2/87 (2.30%)  3/102 (2.94%) 
Renal and urinary disorders                   
Urine abnormality * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  2/94 (2.13%)  0/87 (0.00%)  0/102 (0.00%) 
Reproductive system and breast disorders                   
Abnormal ejaculation /orgasm * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  2/94 (2.13%)  0/87 (0.00%)  0/102 (0.00%) 
Uterine hemorrhage * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  2/94 (2.13%)  0/87 (0.00%)  0/102 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Cough increased * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  0/101 (0.00%)  1/94 (1.06%)  3/87 (3.45%)  1/102 (0.98%) 
Dyspnea * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  1/101 (0.99%)  3/94 (3.19%)  2/87 (2.30%)  3/102 (2.94%) 
Pharyngitis * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  19/461 (4.12%)  0/101 (0.00%)  0/94 (0.00%)  0/87 (0.00%)  0/102 (0.00%) 
Rhinitis * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  22/461 (4.77%)  3/101 (2.97%)  9/94 (9.57%)  4/87 (4.60%)  3/102 (2.94%) 
Sinusitis * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  14/461 (3.04%)  2/101 (1.98%)  1/94 (1.06%)  0/87 (0.00%)  3/102 (2.94%) 
Upper respiratory infection * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  2/101 (1.98%)  2/94 (2.13%)  1/87 (1.15%)  4/102 (3.92%) 
Skin and subcutaneous tissue disorders                   
Night sweats * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  2/101 (1.98%)  0/94 (0.00%)  1/87 (1.15%)  3/102 (2.94%) 
Rash * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  12/461 (2.60%)  0/101 (0.00%)  1/94 (1.06%)  2/87 (2.30%)  1/102 (0.98%) 
Sweating * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  43/461 (9.33%)  8/101 (7.92%)  11/94 (11.70%)  10/87 (11.49%)  18/102 (17.65%) 
Vascular disorders                   
Hypertension * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  0/461 (0.00%)  3/101 (2.97%)  1/94 (1.06%)  2/87 (2.30%)  7/102 (6.86%) 
Vasodilatation * 1  0/126 (0.00%)  0/121 (0.00%)  0/124 (0.00%)  0/122 (0.00%)  16/461 (3.47%)  7/101 (6.93%)  6/94 (6.38%)  2/87 (2.30%)  12/102 (11.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, COSTART
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00401245     History of Changes
Other Study ID Numbers: 3151A2-405
First Submitted: November 17, 2006
First Posted: November 20, 2006
Results First Submitted: September 6, 2011
Results First Posted: October 12, 2011
Last Update Posted: October 26, 2011