Phase 3
N=493
The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms
Vasomotor Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT00401245 ↗Enrolled (actual)
493
Serious AEs
0.3%
Results posted
Oct 2011
Primary outcome: Primary: Number of Participants With Nausea During the First 2 Weeks of Treatment — 24; 31; 28; 43 Participants — p=0.024
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- desvenlafaxine succinate sustained release (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Nausea During the First 2 Weeks of Treatment |
24; 31; 28; 43 | 0.024 sig |
| PRIMARY Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering |
2.26; 2.28; 1.84; 7.07 | < 0.001 sig |
| PRIMARY DESS Total Score at End of Second Week of Tapering |
1.19; 2.44; 4.46; 2.44 | 0.092 |
| PRIMARY DESS Total Score at 1 Week After the End of Tapering |
3.22; 4.11; 1.70; 1.78 | 0.078 |
| SECONDARY Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment |
67; 69; 72; 80 | — |
| SECONDARY Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment |
4.0; 9.1; 6.5; 14.8 | 0.017 sig |
| SECONDARY Number of Participants With Each DESS at the End of First Week of Tapering |
1; 7; 6; 18; 4; 4 | — |
| SECONDARY Number of Participants With Each DESS at the End of Second Week of Tapering |
6; 4; 10; 9; 2; 6 | — |
| SECONDARY Number of Participants With Each DESS One Week After End of Tapering |
6; 4; 6; 5; 2; 0 | — |
| SECONDARY Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment |
2; 3; 1; 4; 1; 6 | — |
| SECONDARY Number of Participants Showing Satisfaction With Tolerability at the End of Tapering |
7; 5; 3; 6; 10; 7 | — |
| SECONDARY Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score |
2.64; 2.71; 2.59; 3.02; 2.37; 2.67 | — |
| SECONDARY Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16 |
4.46; 2.99; 2.85; 2.76; 2.67 | <0.001 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00401245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.