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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.

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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

FieldValue
Enrollment Target 356 participants
Start Date 2017-07-19
Est. Completion 2018-09-19
Phase Phase 2
Astellas Pharma Global Development

168 total trials

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.

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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Source: ClinicalTrials.gov NCT03192176, the US trial registry maintained by the National Library of Medicine. NCT03192176 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.