Conditions: Postmenopausal Symptoms
Keywords: Menopause Vasomotor Symptoms Hot Flashes Perimenopause Climacteric Symptoms Mesafem Low-Dose Mesylate salt of Paroxetine (LDMP)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 614
Healthy volunteers: no

Brief 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.

Detailed description:
This is 12-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg and placebo capsules in subjects with moderate to severe postmenopausal 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

The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

Arms:
arm 1: Brisdelle (paroxetine mesylate) arm 2: Placebo Capsules

Interventions: intervention 1: Brisdelle (paroxetine mesylate) intervention 2: Placebo capsules
Intervention descriptions: intervention 1: Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 intervention 2: Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84

Protocol document: