The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms
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| ClinicalTrials.gov Identifier: NCT00401245 |
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Recruitment Status :
Completed
First Posted : November 20, 2006
Results First Posted : October 12, 2011
Last Update Posted : October 26, 2011
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vasomotor Symptoms | Drug: desvenlafaxine succinate sustained release Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | December 2006 |
| Actual Primary Completion Date : | January 2008 |
| Actual Study Completion Date : | January 2008 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: A |
Drug: desvenlafaxine succinate sustained release
Titration 100 mg |
| Active Comparator: B |
Drug: desvenlafaxine succinate sustained release
Titration 50 mg |
| Active Comparator: C |
Drug: desvenlafaxine succinate sustained release
Titration 25 mg, 50mg |
| Active Comparator: D |
Drug: desvenlafaxine succinate sustained release
Titration 25 mg |
| Active Comparator: E |
Drug: Placebo
Tapering placebo |
| Active Comparator: F |
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, placebo |
| Active Comparator: G |
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, 25 mg |
| Placebo Comparator: H |
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg QOD |
Primary Outcome Measures :
- Number of Participants With Nausea During the First 2 Weeks of Treatment [ Time Frame: Baseline up to Week 2 ]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.
- Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering [ Time Frame: Week 17 ]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.
- DESS Total Score at End of Second Week of Tapering [ Time Frame: Week 18 ]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.
- DESS Total Score at 1 Week After the End of Tapering [ Time Frame: Week 19 ]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.
Secondary Outcome Measures :
- Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment [ Time Frame: Baseline up to Week 2 ]Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
- Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment [ Time Frame: Baseline up to Week 2 ]Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
- Number of Participants With Each DESS at the End of First Week of Tapering [ Time Frame: Week 17 ]DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
- Number of Participants With Each DESS at the End of Second Week of Tapering [ Time Frame: Week 18 ]DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
- Number of Participants With Each DESS One Week After End of Tapering [ Time Frame: Week 19 ]DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
- Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment [ Time Frame: Week 1 and Week 2 ]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.
- Number of Participants Showing Satisfaction With Tolerability at the End of Tapering [ Time Frame: Week 19 ]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.
- Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score [ Time Frame: Week 16 ]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).
- Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16 [ Time Frame: Baseline, 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.
Other Outcome Measures:
- Mean Age of the Participants in Tapering Phase [ Time Frame: Week 17 ]Participants were re-randomized to tapering phase after OL phase.
- Gender of the Participants in Tapering Phase [ Time Frame: Week 17 ]Participants were re-randomized to tapering phase after OL phase.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Generally healthy, postmenopausal woman who seeks treatment for hot flushes.
- Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels >40 mIU/mL.
Exclusion Criteria:
- History of a seizure disorder other than a single childhood febrile seizure.
- History or presence of clinically important hepatic or renal disease or other medical disease.
- Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401245
Locations
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Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00401245 |
| Other Study ID Numbers: |
3151A2-405 |
| First Posted: | November 20, 2006 Key Record Dates |
| Results First Posted: | October 12, 2011 |
| Last Update Posted: | October 26, 2011 |
| Last Verified: | October 2011 |
Additional relevant MeSH terms:
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Desvenlafaxine Succinate Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Physiological Effects of Drugs Antidepressive Agents Psychotropic Drugs |