Trial · NCT01418209
MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms
NCT01418209, Not applicable, Completed, Fred Hutchinson Cancer Center; results first posted 2014-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms. Trials, record NCT01418209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01418209
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms
- NCT number
- NCT01418209
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 339 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
- Hot Flashes, Menopause, Vasomotor Disturbance
- Interventions
- Low-dose 17-ß-estradiol with progesterone taper, Venlafaxine XR, Placebo
- First posted
- 2011-08-17
- Last updated
- 2014-08-27
- Results first posted
- 2014-08-20
- Limitations and caveats
- Findings may be specific to the particular dose of each agent used, treatment period, as well as the preparation and oral administration of estrogen therapy.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4 | Week 4 | Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 4 study assessment to produce a mean daily frequency for week 4. |
| Primary | Frequency of Hot Flashes (Daily Vasomotor Symptom [VMS] Frequency) -- Week 8 | Week 8 | Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 8 study assessment to produce a mean daily frequency for week 8. |
| Secondary | Severity of Hot Flashes -- Week 4 | Week 4 | Measured by self-report diary twice daily (day and night) for 7 days. Severity ratings ranged from 0 to 3 with lower numbers being less severe and higher numbers being more severe. Data from the day and night severity ratings were averaged for a single daily score. The single daily scores for the week prior to the week 4 study assessment were summed and averaged to produce a mean daily VMS severity for week 4. |
| Secondary | Severity of Hot Flashes -- Week 8 | Week 8 | Measured by self-report diary twice daily (day and night) for 7 days. Severity ratings ranged from 0 to 3 with lower numbers being less severe and higher numbers being more severe. Data from the day and night severity ratings were averaged for a single daily score. The single daily scores for the week prior to the week 8 study assessment were summed and averaged to produce a mean daily VMS severity for week 8. |
| Secondary | Bothersomeness of Hot Flashes -- Week 4 | Week 4 | Measured by self-report diary twice daily (day and night) for 7 days. Bothersomeness ratings ranged from 0 to 3 with lower numbers being less bothersome and higher numbers being more bothersome. Data from the day and night bothersomeness ratings were averaged for a single daily score. The single daily scores for the week prior to the week 4 study assessment were summed and averaged to produce a mean daily VMS bothersomeness for week 4. |
| Secondary | Bothersomeness of Hot Flashes -- Week 8 | Week 8 | Measured by self-report diary twice daily (day and night) for 7 days. Bothersomeness ratings ranged from 0 to 3 with lower numbers being less bothersome and higher numbers being more bothersome. Data from the day and night bothersomeness ratings were averaged for a single daily score. The single daily scores for the week prior to the week 8 study assessment were summed and averaged to produce a mean daily VMS bothersomeness for week 8. |
| Secondary | Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 4 | Week 4 | The perceived hot flash related daily interference scale (HFRDIS) is a tool for assessing the impact of hot flashes on quality of life. There are 10 questions with each having a score ranging from 0 to 10. The scores from each question are summed for a total score ranging from 0 to 100. Lower numbers indicate less interference and higher numbers indicate more interference. |
| Secondary | Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 8 | Week 8 | The perceived hot flash related daily interference scale (HFRDIS) is a tool for assessing the impact of hot flashes on quality of life. There are 10 questions with each having a score ranging from 0 to 10. The scores from each question are summed for a total score ranging from 0 to 100. Lower numbers indicate less interference and higher numbers indicate more interference. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4 | Week 4 | Intention-to-treat, i.e., all participants with follow-up data were included. | number of hot flashes per day | MEAN |
| SECONDARY | Severity of Hot Flashes -- Week 4 | Week 4 | Intention-to-treat, i.e., all participants with follow-up data were included. | units on a scale | MEAN |
| SECONDARY | Severity of Hot Flashes -- Week 8 | Week 8 | Intention-to-treat, i.e., all participants with follow-up data were included. | units on a scale | MEAN |
| PRIMARY | Frequency of Hot Flashes (Daily Vasomotor Symptom [VMS] Frequency) -- Week 8 | Week 8 | Intention-to-treat, i.e., all participants with follow-up data were included. | number of hot flashes per day | MEAN |
| SECONDARY | Bothersomeness of Hot Flashes -- Week 4 | Week 4 | Intention-to-treat, i.e., all participants with follow-up data were included. | units on a scale | MEAN |
| SECONDARY | Bothersomeness of Hot Flashes -- Week 8 | Week 8 | Intention-to-treat, i.e., all participants with follow-up data were included. | units on a scale | MEAN |
| SECONDARY | Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 4 | Week 4 | Intention-to-treat, i.e., all participants with follow-up data were included. | units on a scale | MEAN |
| SECONDARY | Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 8 | Week 8 | Intention-to-treat, i.e., all participants with follow-up data were included. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4 | Low-dose 17-ß-estradiol With Progesterone Taper | 5.3 | 95% Confidence Interval 4.2 to 6.5 | number of hot flashes per day | |
| Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4 | Venlafaxine XR | 5.1 | 95% Confidence Interval 4.1 to 6.0 | number of hot flashes per day | |
| Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4 | Placebo | 5.8 | 95% Confidence Interval 4.9 to 6.7 | number of hot flashes per day | |
| Severity of Hot Flashes -- Week 4 | Low-dose 17-ß-estradiol With Progesterone Taper | 0.7 | 95% Confidence Interval 0.6 to 0.9 | units on a scale | |
| Severity of Hot Flashes -- Week 4 | Venlafaxine XR | 0.7 | 95% Confidence Interval 0.5 to 0.8 | units on a scale | |
| Severity of Hot Flashes -- Week 4 | Placebo | 0.8 | 95% Confidence Interval 0.7 to 0.9 | units on a scale | |
| Severity of Hot Flashes -- Week 8 | Low-dose 17-ß-estradiol With Progesterone Taper | 0.6 | 95% Confidence Interval 0.4 to 0.7 | units on a scale | |
| Severity of Hot Flashes -- Week 8 | Venlafaxine XR | 0.6 | 95% Confidence Interval 0.4 to 0.7 | units on a scale | |
| Severity of Hot Flashes -- Week 8 | Placebo | 0.7 | 95% Confidence Interval 0.6 to 0.8 | units on a scale | |
| Frequency of Hot Flashes (Daily Vasomotor Symptom [VMS] Frequency) -- Week 8 | Low-dose 17-ß-estradiol With Progesterone Taper | 3.9 | 95% Confidence Interval 2.9 to 4.9 | number of hot flashes per day |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low-dose 17-ß-Estradiol With Progesterone Taper | 97 | |
| Overall Study | STARTED | Venlafaxine XR | 96 | |
| Overall Study | STARTED | Placebo | 146 | |
| Overall Study | COMPLETED | Low-dose 17-ß-Estradiol With Progesterone Taper | 95 | |
| Overall Study | COMPLETED | Venlafaxine XR | 93 | |
| Overall Study | COMPLETED | Placebo | 142 | |
| Overall Study | NOT COMPLETED | Low-dose 17-ß-Estradiol With Progesterone Taper | 2 | |
| Overall Study | NOT COMPLETED | Venlafaxine XR | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events21
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 | Any fatigue/arousal symptom | General disorders | Low-dose 17-ß-estradiol | 20 | 85 | |
| other | Any fatigue/arousal symptom | General disorders | Venlafaxine XR | 26 | 81 | |
| other | Any fatigue/arousal symptom | General disorders | Placebo | 33 | 127 | |
| other | Any central nervous system symptom | Nervous system disorders | Low-dose 17-ß-estradiol | 22 | 92 | |
| other | Any central nervous system symptom | Nervous system disorders | Venlafaxine XR | 30 | 94 | |
| other | Any central nervous system symptom | Nervous system disorders | Placebo | 36 | 142 | |
| other | Any GI symptom | Gastrointestinal disorders | Low-dose 17-ß-estradiol | 23 | 94 | |
| other | Any GI symptom | Gastrointestinal disorders | Venlafaxine XR | 25 | 93 | |
| other | Any GI symptom | Gastrointestinal disorders | Placebo | 44 | 142 | |
| other | Breast tenderness | Reproductive system and breast disorders | Low-dose 17-ß-estradiol | 5 | 90 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low-dose 17-ß-estradiol | ||
| Total, all-cause mortality | Venlafaxine XR | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Low-dose 17-ß-estradiol | 53 | 97 |
| Total, other adverse events | Venlafaxine XR | 65 | 96 |
| Total, other adverse events | Placebo | 88 | 146 |
| Total, serious adverse events | Low-dose 17-ß-estradiol | 0 | 97 |
| Total, serious adverse events | Venlafaxine XR | 0 | 96 |
| Total, serious adverse events | Placebo | 0 | 146 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01AG032699 | Menopausal Symptoms Initiative-Finding Lasting Answers for Sweats and Hot Flashes | GUTHRIE, KATHERINE ADAMS; LACROIX, ANDREA Z. | FRED HUTCHINSON CANCER RESEARCH CENTER | NATIONAL INSTITUTE ON AGING | 2008 to 2012 | NIH RePORTER |
| U01AG032700 | MSI-FLASH: Relative Efficacy of Hormonal and Non-Hormonal Interventions for VMS | COHEN, LEE S; JOFFE, HADINE | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL INSTITUTE ON AGING | 2008 to 2012 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01418209
GET https://conductscience.org/api/trials/v1/NCT01418209/results?page=2