NCT00401245|CompletedPhase 3Results

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

The Effect of Dose Titration and Dose Tapering on the Tolerability of DVS SR in Women With Vasomotor Symptoms Associated With Menopause: The PRIMMUS (PRIstiq for Managing Menopause and Understanding Symptoms) Study

Pfizer ClinicalTrials.gov

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1 other identifier

3151A2-405

Study Type

interventional

Target

500

Locations

2 countries

Sites

Timeline

RegisteredNov 2006

StartedDec 2006

CompletionJan 2008

Brief Summary

Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

500

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2006

Shorter than P25 for phase_3

Geographic Reach

2 countries

73 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

November 17, 2006

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed

11 days until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed

3.8 years until next milestone

Results Posted

Study results publicly available

October 12, 2011

Completed

Last Updated

October 26, 2011

Status Verified

October 1, 2011

Enrollment Period

1.1 years

First QC Date

November 17, 2006

Results QC Date

September 6, 2011

Last Update Submit

October 24, 2011

Conditions

Vasomotor Symptoms

Outcome Measures

Primary Outcomes (4)

Number of Participants With Nausea During the First 2 Weeks of Treatment
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.
Baseline up to Week 2
Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering
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.
Week 17
DESS Total Score at End of Second Week of Tapering
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.
Week 18
DESS Total Score at 1 Week After the End of Tapering
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.
Week 19

Secondary Outcomes (9)

Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment
Baseline up to Week 2
Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment
Baseline up to Week 2
Number of Participants With Each DESS at the End of First Week of Tapering
Week 17
Number of Participants With Each DESS at the End of Second Week of Tapering
Week 18
Number of Participants With Each DESS One Week After End of Tapering
Week 19
+4 more secondary outcomes

Other Outcomes (2)

Mean Age of the Participants in Tapering Phase
Week 17
Gender of the Participants in Tapering Phase
Week 17