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NCT03192176 · ClinicalTrials.gov registry record · Phase 2
A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)
A Phase 2 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 356
- Enrollment target
NCT03192176: Completed Phase 2 study, sponsored by Astellas Pharma Global Development.
NCT03192176 is a Phase 2 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 356 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03192176, a Phase 2 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 356 participants
- Enrollment target
Study Summary
This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment was administered for 12 weeks to postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per week.
Primary Outcome
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat wit
Interventions
- DRUG Placebo
- DRUG Fezolinetant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2017-07-19 |
| Est. Completion | 2018-09-19 |
| Phase | Phase 2 |
What the finished NCT03192176 record still lists
NCT03192176 is an interventional study that assigns participants to a tested intervention. The registered 356 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 (168% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03192176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03192176 about?
NCT03192176 is a clinical study titled "A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)". This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment was administered for 12 weeks to postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per week.
What is the current status of trial NCT03192176?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 356 participants. The study started on 2017-07-19. Estimated completion is 2018-09-19.
What interventions are being tested in trial NCT03192176?
The interventions under investigation include: Placebo (DRUG), Fezolinetant (DRUG).
Who is sponsoring clinical trial NCT03192176?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03192176's enrollment target sits among peer trials
356 128th of 2000 higher than 1,873 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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