Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Completed
Noven Therapeutics
Phase 2
2008-11-01
This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled
study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe
postmenopausal vasomotor symptoms (VMS), defined as follows:
- Moderate VMS: Sensation of heat with sweating, able to continue activity
- Severe VMS: Sensation of heat with sweating, causing cessation of activity
24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms
Completed
Noven Therapeutics
Phase 3
2010-03-01
To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for
treatment of vasomotor symptoms (VMS) associated with menopause
Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)
Completed
Noven Therapeutics
Phase 3
2011-05-01
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.
Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women
Completed
Noven Therapeutics
Phase 1
2011-07-01
The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and
elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate)
Capsules 7.5 mg when given as a single dose and multiple doses.
Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor
Unknown status
Alphacait, LLC
Phase 2
2017-01-01
This is a single-center, open-label, single-arm, non-randomized study designed to evaluate
PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR)
and biomarkers of cancer therapy based on Alphacait screening system in subjects with
advanced malignant tumor.
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