Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00401245 | The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms | PHASE3 | COMPLETED | 500 | — | — | Dec 1, 2006 | Jan 1, 2008 | Oct 26, 2011 | 74 | United States, Canada +1 |
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.
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: 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: 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.
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | - |
| B | ACTIVE_COMPARATOR | - |
| C | ACTIVE_COMPARATOR | - |
| D | ACTIVE_COMPARATOR | - |
| E | ACTIVE_COMPARATOR | - |
| F | ACTIVE_COMPARATOR | - |
| G | ACTIVE_COMPARATOR | - |
| H | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| desvenlafaxine succinate sustained release | DRUG | Titration 100 mg |
| Placebo | DRUG | Tapering placebo |
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 week...