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NCT04516304 · ClinicalTrials.gov registry record · NA
A Nutritional Supplement on Vasomotor Symptoms in Women
A NA study, sponsored by Pharmavite.
- Completed
- Registry status
- NA
- Development phase
- 118
- Enrollment target
NCT04516304 is a NA study that has completed, run by Pharmavite. The registered enrollment target is 118 participants.
The verdict
NCT04516304, a NA study, has completed, sponsored by Pharmavite.
- COMPLETED
- Registry status
- NA
- Development phase
- 118 participants
- Enrollment target
Study Summary
Vasomotor symptoms (VMS), such as flushes, sweating, and sleep disturbances, are experienced by up to 80% of women during the menopausal transition. Night sweats, which are hot flushes that occur at night, can be particularly bothersome in women and contribute to disturbed sleep. These symptoms occur mainly during the 1-3 years prior to menopause (late perimenopause) and early menopause (\~4 years after menstruation ceases). Many women look to supplements for the management of menopausal symptoms. Soy isoflavones and their metabolites are one category of dietary supplements that have been extensively studied for the management of VMS. The most active soy isoflavone is S-equol, which is not found directly in soy, but rather is the metabolite that is produced by gut microflora from consumption of the soy isoflavone daidzein. However, only 20-30% of US women are actually able to produce S-equol from the consumption of daidzein. Equelle® is a currently available dietary supplement that has S-equol as its active component, which allows the delivery of the active soy isoflavone metabolite directly without dependence on the gut microflora metabolism. The intention of this study is to assess the effect of a product containing S-equol on the management of VMS in normally healthy women. Condition or disease: Vasomotor Symptoms Intervention/treatment: Dietary Supplement: S-equol Dietary Supplement: Placebo
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT S-equol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2019-03-27 |
| Est. Completion | 2020-05-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04516304
The ClinicalTrials.gov registry entry for NCT04516304 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharmavite, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04516304 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04516304 about?
NCT04516304 is a clinical study titled "A Nutritional Supplement on Vasomotor Symptoms in Women". Vasomotor symptoms (VMS), such as flushes, sweating, and sleep disturbances, are experienced by up to 80% of women during the menopausal transition. Night sweats, which are hot flushes that occur at night, can be particularly bothersome in women and contribute to disturbed sleep. These symptoms occu...
What is the current status of trial NCT04516304?
This trial is currently completed. It is a NA study. The enrollment target is 118 participants. The study started on 2019-03-27. Estimated completion is 2020-05-22.
What interventions are being tested in trial NCT04516304?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), S-equol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04516304?
This trial is sponsored by Pharmavite, which has 5 total clinical trials registered on ClinicalTrials.gov.
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