Completed PHASE3 INTERVENTIONAL 2-arm NCT01361308

Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS) (N30-003)

A Phase 3, Twelve-Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Mesafem (Paroxetine Mesylate) Capsules in the Treatment of Vasomotor Symptoms Associated With Menopause

Sponsor: Noven Therapeutics

Conditions Postmenopausal Symptoms

Interventions Brisdelle (paroxetine mesylate) Placebo capsules

Updated 7 times since 2017 Last updated: Oct 14, 2015 Started: May 31, 2011 Primary completion: Dec 31, 2011 Completion: Feb 29, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Postmenopausal Symptoms, this trial is completed. The trial is conducted by Noven Therapeutics and has accumulated 7 data snapshots since 2011. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

May 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Noven Therapeutics

Data source: Noven Therapeutics

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albuquerque, United States , Ann Arbor, United States , Arlington Heights, United States , Austin, United States , Benzonia, United States , Boise, United States , Bradenton, United States , Brockton, United States , Brooksville, United States , Bryan, United States and 56 more locations