Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01101841 · ClinicalTrials.gov registry record · Phase 3
24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms
A Phase 3 study of Hot Flashes, sponsored by Noven Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 570
- Enrollment target
- 20
- Study locations
NCT01101841: Completed Phase 3 study of Hot Flashes, sponsored by Noven Therapeutics.
NCT01101841 is a Phase 3 study of Hot Flashes that has completed, run by Noven Therapeutics. The registered enrollment target is 570 participants, above the 147-participant average among 23 other Hot Flashes trials with a reported enrollment target (288% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01101841, a Phase 3 study of Hot Flashes, has completed, sponsored by Noven Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 570 participants
- Enrollment target
- 20
- Study locations
Study Summary
To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause
Primary Outcome
Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week. The results reported are: * Mean Baseline frequency of moderate to severe VMS * Mean change in frequency of moderate to severe VMS from baseline to Week 4 * Mean change in frequency of moderate to severe VMS from baseline to Week 12
Conditions Studied
Interventions
- DRUG Placebo capsules
- DRUG Brisdelle (paroxetine mesylate)
Study Locations (20)
Florida
- Visions Clinical Research - Boynton Beach
- Meridien Research - Brooksville
- Women's Medical Research Group, LLC - Clearwater
- Altus Research - Lake Worth
- Anchor Research Center - Naples
- Comprehensive Clinical Trials, LLC - West Palm Beach
California
- Genesis Center For Clinical Research - San Diego
- Apex Research Institute - Santa Ana
Georgia
- Soapstone Center for Clinical Research - Decatur
- Mount Vernon Clinical Research, LLC - Sandy Springs
North Carolina
- Hawthorne Research - Greensboro
- Hawthorne Medical Research, Inc. - Winston-Salem
Alabama
- Montgomery Women's Health Associates, PC - Montgomery
Arizona
- East Valley Family Physicians PLC - Chandler
Colorado
- Downtown Women's Health Care - Denver
Connecticut
- Chase Medical Research, LLC - Waterbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 570 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT01101841 record still lists
NCT01101841 is an interventional study that assigns participants to a tested intervention. The registered 570 participants enrollment target is mid-sized for trials with a published cap, above the 147-participant average among 23 other Hot Flashes trials with a reported enrollment target (288% higher).
The record links to 1 condition, with Hot Flashes appearing as the primary indexed condition, and to 2 interventions - of which Placebo capsules is the first listed.
NCT01101841 names 20 study sites across 12 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01101841 about?
NCT01101841 is a clinical study titled "24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms". To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause
What is the current status of trial NCT01101841?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 570 participants. The study started on 2010-03. Estimated completion is 2011-11.
What conditions does trial NCT01101841 study?
This clinical trial studies the following conditions: Hot Flashes.
What interventions are being tested in trial NCT01101841?
The interventions under investigation include: Placebo capsules (DRUG), Brisdelle (paroxetine mesylate) (DRUG).
Who is sponsoring clinical trial NCT01101841?
This trial is sponsored by Noven Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01101841 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hot Flashes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01101841's enrollment target sits among peer trials
570 2nd of 23 the highest of 23 other Hot Flashes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hot Flashes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer
COMPLETED · Phase 3
-
Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture
RECRUITING · NA
-
Hot Flashes and Neurovascular Function in Women
RECRUITING · NA
-
JDS-HF3.0 Supplementation on Menopause Related Quality of Life Outcomes in Postmenopausal Women
RECRUITING · NA
-
Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
RECRUITING · NA
-
Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women Using Inspiratory Muscle Strength Training
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05000645 · 570 participants · NA
Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
- NCT06239844 · 570 participants · NA
Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English
- NCT06701903 · 570 participants · Phase 2
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
- NCT07266831 · 570 participants · Phase 2
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia