Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00683800

First received: May 21, 2008

Last updated: July 21, 2011

Last verified: July 2011

History of Changes

Results First Received: April 21, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Vasomotor Symptoms
Interventions:	Drug: desvenlafaxine succinate (DVS) SR 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 3784 participants were screened, of which 1598 participants were screen failures and 2186 participants were randomly assigned to treatment.

Reporting Groups

	Description
DVS SR 100 mg	Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
Placebo	Matching placebo tablets daily until Day 365 or early withdrawal.

Participant Flow: Overall Study

	DVS SR 100 mg	Placebo
STARTED	1101	1085
Treated	1066	1052
COMPLETED	669	719
NOT COMPLETED	432	366
Adverse Event	195	102
Death	0	1
Lost to Follow-up	57	44
Unspecified	5	2
Protocol Violation	13	16
Withdrawal by Subject	66	64
Lack of Efficacy	61	104
Randomized, not treated	35	33

Baseline Characteristics

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Reporting Groups

	Description
DVS SR 100 mg	Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
Placebo	Matching placebo tablets daily until Day 365 or early withdrawal.
Total	Total of all reporting groups

Baseline Measures

	DVS SR 100 mg	Placebo	Total
Number of Participants [units: participants]	1066	1052	2118
Age [units: Years] Mean ± Standard Deviation	53.95 ± 4.90	53.59 ± 4.91	53.77 ± 4.90
Gender [units: Participants]
Female	1066	1052	2118
Male	0	0	0
Daily number of moderate and severe hot flushes ^[1] [units: Hot Flushes] Mean ± Standard Deviation	11.67 ± 5.62	11.91 ± 5.71	11.79 ± 5.66
Daily severity score of hot flushes ^[2] [units: Units on a scale] Mean ± Standard Deviation	2.36 ± 0.34	2.39 ± 0.35	2.37 ± 0.34

[1]	Average daily number of moderate and severe hot flushes was calculated as the sum of number of moderate and severe hot flushes on each day divided by number of days with data. Moderate: sensation of heat with sweating; able to continue activity; and severe: sensation of heat with sweating; causing cessation of activity. Participants analysed were 184 and 181 for DVS SR 100 mg group and placebo group, respectively.
[2]	Severity: mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). Average daily severity of hot flushes for each time period was calculated as (1Number of mild+2Number of moderate+3*Number of severe)/(Total number of hot flushes). For days with no hot flushes, severity score was set as 0. As this was derived from count data, there was no maximum; minimum score was 0; the higher values showed worse outcomes. n=184 (DVS SR 100 mg group); n=181 (placebo group).

[1]

Average daily number of moderate and severe hot flushes was calculated as the sum of number of moderate and severe hot flushes on each day divided by number of days with data. Moderate: sensation of heat with sweating; able to continue activity; and severe: sensation of heat with sweating; causing cessation of activity. Participants analysed were 184 and 181 for DVS SR 100 mg group and placebo group, respectively.

[2]

Severity: mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). Average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For days with no hot flushes, severity score was set as 0. As this was derived from count data, there was no maximum; minimum score was 0; the higher values showed worse outcomes. n=184 (DVS SR 100 mg group); n=181 (placebo group).

Outcome Measures

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1. Primary:

Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4 [ Time Frame: Baseline and Week 4 ]

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2. Primary:

Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12 [ Time Frame: Baseline and Week 12 ]

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3. Primary:

Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4 [ Time Frame: Baseline and Week 4 ]

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4. Primary:

Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12 [ Time Frame: Baseline and Week 12 ]

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5. Primary:

Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events [ Time Frame: Baseline up to Month 12 ]

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6. Secondary:

Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes [ Time Frame: Baseline and Week 12 ]

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7. Secondary:

Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes [ Time Frame: Baseline, Week 4 and Week 12 ]

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8. Secondary:

Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes [ Time Frame: Baseline, Week 4 and Week 12 ]

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9. Secondary:

Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes [ Time Frame: Week 12 ]

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10. Secondary:

Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12 [ Time Frame: Baseline, Month 6 and Month 12 ]

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11. Secondary:

Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12 [ Time Frame: Baseline, Month 6 and Month 12 ]

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12. Secondary:

Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12 [ Time Frame: Baseline and Week 12 ]

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13. Secondary:

Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6 [ Time Frame: Baseline and Month 6 ]

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14. Secondary:

Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12 [ Time Frame: Baseline and Month 12 ]

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15. Secondary:

Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12 [ Time Frame: Week 12 ]

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16. Secondary:

Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6 [ Time Frame: Month 6 ]

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17. Secondary:

Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12 [ Time Frame: Month 12 ]

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18. Secondary:

Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12 [ Time Frame: Week 12 ]

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19. Secondary:

Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6 [ Time Frame: Month 6 ]

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20. Secondary:

Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12 [ Time Frame: Month 12 ]

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21. Secondary:

Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12 [ Time Frame: Week 12 ]

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22. Secondary:

Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6 [ Time Frame: Month 6 ]

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23. Secondary:

Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12 [ Time Frame: Month 12 ]

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24. Secondary:

Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12 [ Time Frame: Week 12 ]

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25. Secondary:

Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6 [ Time Frame: Month 6 ]

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26. Secondary:

Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12 [ Time Frame: Month 12 ]

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27. Other Pre-specified:

Number of Participants With Adjudicated Cerebrovascular Events - Any Stroke [ Time Frame: Baseline up to Month 12 ]

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28. Other Pre-specified:

Number of Participants With Adjudicated Cerebrovascular Events - Probable TIA [ Time Frame: Baseline up to Month 12 ]

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29. Other Pre-specified:

Number of Participants With Ischemic Heart Disease [ Time Frame: Baseline up to Month 12 ]

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30. Other Pre-specified:

Number of Participants With Hepatic Events [ Time Frame: Baseline up to Month 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
GCS scales were analyzed only for main study efficacy population.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided by Pfizer

Publications automatically indexed to this study:

Archer DF, Pinkerton JV, Guico-Pabia CJ, Hwang E, Cheng RF; Study 3353 Investigators. Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year in women with vasomotor symptoms associated with menopause. Menopause. 2013 Jan;20(1):47-56. doi: 10.1097/gme.0b013e3182775fe9.

Pinkerton JV, Archer DF, Guico-Pabia CJ, Hwang E, Cheng RF. Maintenance of the efficacy of desvenlafaxine in menopausal vasomotor symptoms: a 1-year randomized controlled trial. Menopause. 2013 Jan;20(1):38-46. doi: 10.1097/GME.0b013e318274699f.

Pinkerton JV, Constantine G, Hwang E, Cheng RF; Study 3353 Investigators. Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial. Menopause. 2013 Jan;20(1):28-37. doi: 10.1097/gme.0b013e31826421a8.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00683800 History of Changes
Other Study ID Numbers:	3151A2-3353, B2061011
Study First Received:	May 21, 2008
Results First Received:	April 21, 2011
Last Updated:	July 21, 2011
Health Authority:	United States: Food and Drug Administration

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