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NCT00962585 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients
A Phase 2 study, sponsored by Ausio Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 169
- Enrollment target
NCT00962585: Completed Phase 2 study, sponsored by Ausio Pharmaceuticals.
NCT00962585 is a Phase 2 study that has completed, run by Ausio Pharmaceuticals. The registered enrollment target is 169 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00962585, a Phase 2 study, has completed, sponsored by Ausio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 169 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and effectiveness of S-equol in menopausal patients with hot flushes and night sweats.
Primary Outcome
The primary efficacy endpoint for this study was the change from Baseline (Day 0) in the frequency of MSVS (difference between Baseline \[2-week run-in period\] and Week 4), where the baseline MSVS frequency was captured over 14 ± 2 day period. Moderate is defined as "sensation of heat with sweating, able to continue activity"; severe is defined as "sensation of heat with sweating, causing cessation of activity". Patients used the take-home daily diary to record MSVS information during the run-i
Interventions
- DRUG Placebo
- DRUG S-equol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT00962585 record still lists
NCT00962585 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00962585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00962585 about?
NCT00962585 is a clinical study titled "Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients". The purpose of this study is to assess the safety and effectiveness of S-equol in menopausal patients with hot flushes and night sweats.
What is the current status of trial NCT00962585?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2010-06. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00962585?
The interventions under investigation include: Placebo (DRUG), S-equol (DRUG).
Who is sponsoring clinical trial NCT00962585?
This trial is sponsored by Ausio Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00962585's enrollment target sits among peer trials
169 403rd of 2000 higher than 1,598 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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