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NCT06049797 · ClinicalTrials.gov registry record
A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
A clinical trial of Hot Flashes, sponsored by Astellas Pharma Global Development.
- Active
- Registry status
- 999
- Enrollment target
- 20
- Study locations
NCT06049797 is a study of Hot Flashes that is active but no longer recruiting, run by Astellas Pharma Global Development. The registered enrollment target is 999 participants, above the 128-participant average among 23 other Hot Flashes trials with a reported enrollment target (680% higher). The trial reports 20 study locations across 7 states.
The verdict
NCT06049797, a study of Hot Flashes, is active but no longer recruiting, sponsored by Astellas Pharma Global Development.
- ACTIVE NOT RECRUITING
- Registry status
- 999 participants
- Enrollment target
- 20
- Study locations
Study Summary
Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause. This study will follow women going through menopause who have hot flashes and night sweats that cause them bother. They will be starting a non-hormonal therapy prescribed by their healthcare provider (HCP) to treat these symptoms. The women will visit their HCP's office, research center, or both. They will receive prescriptions for the non-hormonal therapy from their HCP for up to 1 year. This real-world study will provide information on outcomes from various non-hormonal therapies. The study sponsor (Astellas) will not decide which therapy the women receive. However, the sponsor will provide instructions on when the women visit their clinic, and what is recorded during the study. Some of the visits will be in-person, but most will be virtual. The virtual visits can be carried out at home using a smartphone, tablet or computer. The main aim of the study is to check if the hot flashes and night sweats that bother women change after 12 weeks (3 months) of treatment. The study will also check the women's sleep patterns, their productivity at work, and their general well-being before and after starting treatment. The overall safety of the non-hormonal therapies will also be examined.
Conditions Studied
Interventions
- DRUG Escitalopram
- DRUG Fezolinetant
- DRUG Paroxetine
- DRUG Citalopram
- DRUG Desvenlafaxine
Study Locations (20)
Florida
- Accel Research Sites - DeLand
- Nextlevel Research Center - Doral
- Multi-Specialty Research Associates, Inc. (WR-MSRA, LLC) - Lake City
- Altus Research - Lake Worth
- Suncoast Research Associates, LLC - Miami
- Dr. Jarrett's Wellness Center - Miami
- Complete Health Research - Ormond Beach
- Comprehensive Clinical Trials, Llc - West Palm Beach
California
- Torrance Clinical Research Institute,Inc - Lomita
- Dream Team Clinical Research - Pomona
- Wake Research - Medical Center for Clinical Research WR-MCCR, LLC - San Diego
- Millennium Clinical Trials LLC - Simi Valley
- Bayview Research Group, LLC - Valley Village
Alabama
- Alabama Clinical Therapeutics - Birmingham
- Accel Research Sites-Cahaba Medical Care-OBGYN - Birmingham
Georgia
- Agile Clinical Research Trials, LLC - Atlanta
- Alpha Clinical Research Georgia - Dunwoody
Arizona
- Precision Trials AZ, LLC - Phoenix
Colorado
- University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus - Aurora
Idaho
- Clinical Research Prime - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 999 participants |
| Start Date | 2023-11-15 |
| Est. Completion | 2026-05-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06049797
The ClinicalTrials.gov registry entry for NCT06049797 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 999 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 128-participant average among 23 other Hot Flashes trials with a reported enrollment target (680% higher). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hot Flashes appearing as the primary indexed condition, and to 5 interventions - of which Escitalopram is the first listed.
NCT06049797 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT06049797 about?
NCT06049797 is a clinical study titled "A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats". Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause. This study will follow women going through menopause who have hot flashes and night sweats that cause them bother. They will be starting a non-hormonal therapy prescri...
What is the current status of trial NCT06049797?
This trial is currently active not recruiting. The enrollment target is 999 participants. The study started on 2023-11-15. Estimated completion is 2026-05-31.
What conditions does trial NCT06049797 study?
This clinical trial studies the following conditions: Hot Flashes.
What interventions are being tested in trial NCT06049797?
The interventions under investigation include: Escitalopram (DRUG), Fezolinetant (DRUG), Paroxetine (DRUG), Citalopram (DRUG), Desvenlafaxine (DRUG).
Who is sponsoring clinical trial NCT06049797?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06049797 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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