Trial · NCT00683800
Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women
NCT00683800, Phase 3, Completed, Pfizer; results first posted 2011-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women. Trials, record NCT00683800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00683800
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women
- NCT number
- NCT00683800
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,186 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Vasomotor Symptoms
- Interventions
- desvenlafaxine succinate (DVS) SR, Placebo
- First posted
- 2008-05-23
- Last updated
- 2011-08-17
- Results first posted
- 2011-08-17
- Limitations and caveats
- GCS scales were analyzed only for main study efficacy population.
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4 | Baseline and Week 4 | The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. |
| Primary | Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12 | Baseline and Week 12 | The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. |
| Primary | Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4 | Baseline and Week 4 | Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1\*Number of mild+2\*Number of moderate+3\*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes. |
| Primary | Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12 | Baseline and Week 12 | Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1\*Number of mild+2\*Number of moderate+3\*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes. |
| Primary | Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events | Baseline up to Month 12 | Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting. |
| Secondary | Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes | Baseline and Week 12 | A mean decrease from baseline of at least 5.35 moderate to severe hot flushes at week 12 in the participants was considered clinically meaningful. |
| Secondary | Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes | Baseline, Week 4 and Week 12 | The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. |
| Secondary | Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes | Baseline, Week 4 and Week 12 | The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. |
| Secondary | Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes | Week 12 | Time to response was defined as the time-to-first 50% reduction in the average daily number of moderate to severe hot flushes over 3 consecutive days. |
| Secondary | Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12 | Baseline, Month 6 and Month 12 | The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Adjusted mean was calculated by using change from baseline as response variable, treatment as factor, and baseline as covariate using the observed cases. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4 | Baseline and Week 4 | Modified Intent-to-Treat(MITT) population: Participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks. Last observation carried forward (LOCF) method was used. 1 participant in each group did not have data till Week 4. | Hot Flushes | MEAN |
| PRIMARY | Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12 | Baseline and Week 12 | MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method. | Hot Flushes | MEAN |
| PRIMARY | Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4 | Baseline and Week 4 | MITT population: All participants randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using LOCF method. 1 participant in each group did not have data till Week 4. | Units on a Scale | MEAN |
| PRIMARY | Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12 | Baseline and Week 12 | MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method. | Units on a Scale | MEAN |
| PRIMARY | Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events | Baseline up to Month 12 | Safety population included all randomized participants who received at least 1 dose of study medication. | Participants | NUMBER |
| SECONDARY | Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes | Baseline and Week 12 | MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes | Baseline, Week 4 and Week 12 | MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes | Baseline, Week 4 and Week 12 | MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method. | Percentage of participants | NUMBER |
| SECONDARY | Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes | Week 12 | MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. | Days | MEDIAN |
| SECONDARY | Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12 | Baseline, Month 6 and Month 12 | MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. | Hot Flushes | MEAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group250
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4 | DVS SR 100 mg | -6.52 | Standard Error 0.33 | Hot Flushes | |
| Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4 | Placebo | -3.64 | Standard Error 0.33 | Hot Flushes | |
| Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12 | DVS SR 100 mg | -7.31 | Standard Error 0.35 | Hot Flushes | |
| Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12 | Placebo | -4.52 | Standard Error 0.35 | Hot Flushes | |
| Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4 | DVS SR 100 mg | -0.47 | Standard Error 0.04 | Units on a Scale | |
| Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4 | Placebo | -0.19 | Standard Error 0.04 | Units on a Scale | |
| Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12 | DVS SR 100 mg | -0.59 | Standard Error 0.05 | Units on a Scale | |
| Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12 | Placebo | -0.28 | Standard Error 0.05 | Units on a Scale | |
| Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events | DVS SR 100 mg | Any ischemic CV event | 0 | Participants | |
| Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events | Placebo | Any ischemic CV event | 1 | Participants |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DVS SR 100 mg | 1,101 | |
| Overall Study | STARTED | Placebo | 1,085 | |
| Overall Study | Treated | DVS SR 100 mg | 1,066 | |
| Overall Study | Treated | Placebo | 1,052 | |
| Overall Study | COMPLETED | DVS SR 100 mg | 669 | |
| Overall Study | COMPLETED | Placebo | 719 | |
| Overall Study | NOT COMPLETED | DVS SR 100 mg | 432 | |
| Overall Study | NOT COMPLETED | Placebo | 366 |
Source ClinicalTrials.gov
Adverse events2,000
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | DVS SR 100 mg | 7 | 1,066 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 5 | 1,052 | |
| other | Leukopenia | Blood and lymphatic system disorders | DVS SR 100 mg | 3 | 1,066 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 4 | 1,052 | |
| other | Lymph node pain | Blood and lymphatic system disorders | DVS SR 100 mg | 0 | 1,066 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Placebo | 1 | 1,052 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | DVS SR 100 mg | 0 | 1,066 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Placebo | 1 | 1,052 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | DVS SR 100 mg | 4 | 1,066 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 7 | 1,052 |
1 to 10 of 2,000Source ClinicalTrials.gov
See all 2,000 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DVS SR 100 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | DVS SR 100 mg | 941 | 1,066 |
| Total, other adverse events | Placebo | 872 | 1,052 |
| Total, serious adverse events | DVS SR 100 mg | 43 | 1,066 |
| Total, serious adverse events | Placebo | 36 | 1,052 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DVS SR 100 mg vs Placebo: Number of Participants With Hepatic Events | Trial comparisons |
| DVS SR 100 mg vs Placebo: Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes | Trial comparisons |
| DVS SR 100 mg vs Placebo: Number of Participants With Adjudicated Cerebrovascular Events - Probable TIA | Trial comparisons |
| DVS SR 100 mg vs Placebo: Number of Participants With Ischemic Heart Disease | Trial comparisons |
| DVS SR 100 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00683800
GET https://conductscience.org/api/trials/v1/NCT00683800/registered?page=2