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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 is a Phase 3 study that has completed, run by Noven Therapeutics. The registered enrollment target is 614 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01361308
The ClinicalTrials.gov registry entry for NCT01361308 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 614 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Noven Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo capsules is the first listed.
NCT01361308 reports 0 study locations.
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.
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