At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Brisdelle (paroxetine mesylate)drug
Likely dose
Brisdelle (paroxetine mesylate) 7.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Pharmacokinetics of Paroxetine Following Single and Repeat Oral Administration of Mesafem (7.5 mg Paroxetine Mesylate) Capsules in Healthy Postmenopausal Women
In Brief
A Phase 1 clinical trial evaluating Brisdelle (paroxetine mesylate) for Postmenopausal Symptoms. Completed, enrolled 24 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Symptoms
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
Primary CompletionAug 2011
First PostedApr 2013
TodayJul 2026
First PostedApr 11, 2013
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.2 years ago
Interventions
Brisdelle (paroxetine mesylate)drug
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.