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NCT01418209 · ClinicalTrials.gov registry record · NA
MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms
A NA study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 339
- Enrollment target
NCT01418209: Completed NA study, sponsored by Fred Hutchinson Cancer Center.
NCT01418209 is a NA study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 339 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01418209, a NA study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 339 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the efficacy of both low-dose oral (by mouth) 17-ß-estradiol and the non-hormonal drug venlafaxine XR compared to placebo in reducing hot flashes. Included in this objective is the intention to compare venlafaxine XR to estradiol therapy, to provide evidence of the relative efficacy of venlafaxine to what is currently considered the most established but also a controversial therapy. 17-ß-estradiol is a type of estrogen. Venlafaxine XR is the extended release (XR) version of venlafaxine. Venlafaxine XR is an serotonin-norepinephrine reuptake inhibitor (SNRI). A placebo is a substance containing no medication.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Venlafaxine XR
- DRUG Low-dose 17-ß-estradiol with progesterone taper
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 339 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-01 |
| Phase | NA |
What the finished NCT01418209 record still lists
NCT01418209 is an interventional study that assigns participants to a tested intervention. The registered 339 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01418209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01418209 about?
NCT01418209 is a clinical study titled "MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms". The primary objective of this study is to determine the efficacy of both low-dose oral (by mouth) 17-ß-estradiol and the non-hormonal drug venlafaxine XR compared to placebo in reducing hot flashes. Included in this objective is the intention to compare venlafaxine XR to estradiol therapy, to provid...
What is the current status of trial NCT01418209?
This trial is currently completed. It is a NA study. The enrollment target is 339 participants. The study started on 2011-11. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01418209?
The interventions under investigation include: Placebo (DRUG), Venlafaxine XR (DRUG), Low-dose 17-ß-estradiol with progesterone taper (DRUG).
Who is sponsoring clinical trial NCT01418209?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01418209's enrollment target sits among peer trials
339 305th of 2000 higher than 1,696 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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