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NCT01361308 · ClinicalTrials.gov registry record · Phase 3
Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)
A Phase 3 study, sponsored by Noven Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 614
- Enrollment target
NCT01361308: Completed Phase 3 study, sponsored by Noven Therapeutics.
NCT01361308 is a Phase 3 study that has completed, run by Noven Therapeutics. The registered enrollment target is 614 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01361308, a Phase 3 study, has completed, sponsored by Noven Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 614 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety \& efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause.
Primary Outcome
Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week. The results reported are: * Mean Baseline frequency of moderate to severe VMS * Mean change in frequency of moderate to severe VMS from baseline to Week 4 * Mean change in frequency of moderate to severe VMS from baseline to Week 12.
Interventions
- DRUG Placebo capsules
- DRUG Brisdelle (paroxetine mesylate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 614 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-02 |
| Phase | Phase 3 |
What the finished NCT01361308 record still lists
NCT01361308 is an interventional study that assigns participants to a tested intervention. The registered 614 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo capsules is the first listed.
NCT01361308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01361308 about?
NCT01361308 is a clinical study titled "Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)". The purpose of this study is to assess the safety \& efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause.
What is the current status of trial NCT01361308?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 614 participants. The study started on 2011-05. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01361308?
The interventions under investigation include: Placebo capsules (DRUG), Brisdelle (paroxetine mesylate) (DRUG).
Who is sponsoring clinical trial NCT01361308?
This trial is sponsored by Noven Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01361308's enrollment target sits among peer trials
614 593rd of 2000 higher than 1,403 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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