Conditions: Hot Flashes
Keywords: Menopause Vasomotor Symptoms Hot flash Perimenopause Nonhormonal therapies Climacteric symptoms Mesafem Low-Dose Mesylate salt of Paroxetine (LDMP)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 102
Healthy volunteers: no

Brief summary:
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

Detailed description:
Eligible subjects will be entered into a 1-week observation period followed by a 1-week run-in period. Following completion of the run-in period, eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio. Study drug will be administered once daily at bedtime. Symptom assessment questionnaires will be administered at baseline and at Day 28 and Day 57 visits.

Arms:
arm 1: Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. arm 2: Eligible subjects will be randomized to receive a sugar pill.

Interventions: intervention 1: Brisdelle (paroxetine mesylate) intervention 2: Sugar pill
Intervention descriptions: intervention 1: Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg. intervention 2: Subjects will receive a sugar pill.

Protocol document: