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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
500
Titration 100 mg
Titration 50 mg
Titration 25 mg, 50mg
Titration 25 mg
Tapering placebo
Tapering 50 mg, placebo
Tapering 50 mg, 25 mg
Tapering 50 mg QOD
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Beverly Hills, California, United States
Pfizer Investigational Site
Encinitas, California, United States
Pfizer Investigational Site
Foothill Ranch, California, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 19
Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment
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
Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment
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
Number of Participants With Each DESS 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.
Time frame: Week 17
Number of Participants With Each DESS at the 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.
Time frame: Week 18
Number of Participants With Each DESS One Week After End of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Time frame: Week 19
Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment
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
Number of Participants Showing Satisfaction With Tolerability at the End of Tapering
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Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Upland, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Longmont, Colorado, United States
...and 64 more locations
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
Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score
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
Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16
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