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NCT01178892 · ClinicalTrials.gov registry record · NA
MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation
A NA study of Menopause and Hot Flashes, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 355
- Enrollment target
- 3
- Study locations
NCT01178892: Completed NA study of Menopause and Hot Flashes, sponsored by Fred Hutchinson Cancer Center.
NCT01178892 is a NA study of Menopause and Hot Flashes that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 355 participants, below the 9,388-participant average among 54 other Menopause trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01178892, a NA study of Menopause and Hot Flashes, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 355 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study is the second clinical trial to be conducted by the Menopause Strategies - Finding Lasting Answers for Symptoms and Health (MsFLASH) research network, a group of investigators conducting clinical trials designed to find new ways to alleviate the most common, bothersome symptoms of the menopausal transition. In this twelve-week clinical trial, 374 women aged 40-62 who are in the late menopausal transition or postmenopausal and experiencing bothersome hot flashes will be randomized to one of three behavioral intervention groups: yoga, exercise, or usual activity. All women will simultaneously be randomized to receive omega-3 supplementation or a matching placebo. The primary aims of this trial are to compare the magnitude of changes in perceived, self-reported frequency and bother of vasomotor symptoms (VMS) before and after the intervention between yoga and the usual activity comparison group, between exercise and the usual activity comparison group, and between omega-3 fatty acid supplementation or placebo. The hypotheses to be tested are: 1. Women assigned to yoga will report lower frequency and less VMS bother than women assigned to the usual activity group at the end of a 12-week study period. 2. Women assigned to aerobic exercise at moderate-vigorous intensity will report lower frequency and less VMS bother than women assigned to the usual activity group at the end of a 12-week study period. 3. Women assigned to omega-3 fatty acid supplementation will report lower frequency and less VMS bother than women assigned to the placebo group at the end of a 12-week study period. The omega-3 component of the study is double-blinded. For yoga, exercise, and usual activity, the outcomes assessors are blinded to the randomization assignments.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Omega-3
- BEHAVIORAL Exercise
- BEHAVIORAL Yoga
- BEHAVIORAL Usual Activity
Study Locations (3)
California
- Kaiser Division of Research - Oakland
Indiana
- Indiana University - Indianapolis
Washington
- Group Health Research Institute - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 355 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-05 |
| Phase | NA |
What the finished NCT01178892 record still lists
NCT01178892 is an interventional study that assigns participants to a tested intervention. The registered 355 participants enrollment target is mid-sized for trials with a published cap, below the 9,388-participant average among 54 other Menopause trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Menopause appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01178892 reports a single indexed study location in California, Indiana, Washington.
Frequently Asked Questions
What is clinical trial NCT01178892 about?
NCT01178892 is a clinical study titled "MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation". This study is the second clinical trial to be conducted by the Menopause Strategies - Finding Lasting Answers for Symptoms and Health (MsFLASH) research network, a group of investigators conducting clinical trials designed to find new ways to alleviate the most common, bothersome symptoms of the men...
What is the current status of trial NCT01178892?
This trial is currently completed. It is a NA study. The enrollment target is 355 participants. The study started on 2010-11. Estimated completion is 2012-05.
What conditions does trial NCT01178892 study?
This clinical trial studies the following conditions: Menopause, Hot Flashes, Vasomotor Symptoms.
What interventions are being tested in trial NCT01178892?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Omega-3 (DIETARY_SUPPLEMENT), Exercise (BEHAVIORAL), Yoga (BEHAVIORAL), Usual Activity (BEHAVIORAL).
Who is sponsoring clinical trial NCT01178892?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01178892 being conducted?
This trial has 3 study locations across California, Indiana, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01178892's enrollment target sits among peer trials
355 6th of 54 higher than 49 of 54 other Menopause trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Menopause 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.
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