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NCT03034018 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT03034018: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT03034018 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03034018, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.
Primary Outcome
The Insomnia Severity Index (ISI) is a scale comprising seven questions scored 0-3. The total ISI score is the sum of all questions, with a total range from 0-21 with higher values indicating worse insomnia. Within-person change in ISI score from baseline to 4 weeks was calculated.
Interventions
- DRUG placebo
- DRUG suvorexant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-05-25 |
| Est. Completion | 2020-04-03 |
| Phase | Phase 4 |
What the finished NCT03034018 record still lists
NCT03034018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT03034018 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03034018 about?
NCT03034018 is a clinical study titled "Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia". The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.
What is the current status of trial NCT03034018?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2017-05-25. Estimated completion is 2020-04-03.
What interventions are being tested in trial NCT03034018?
The interventions under investigation include: placebo (DRUG), suvorexant (DRUG).
Who is sponsoring clinical trial NCT03034018?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03034018's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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