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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: Active study of Hot Flashes, sponsored by Astellas Pharma Global Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MENQoL is a 29-item patient reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL.
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 |
What the registry record for NCT06049797 still lists
NCT06049797 is an observational study that tracks outcomes without assigning an intervention. The registered 999 participants enrollment target is mid-sized for trials with a published cap, above the 128-participant average among 23 other Hot Flashes trials with a reported enrollment target (680% higher).
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 names 20 study sites across 7 states, led by 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.
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 NCT06049797's enrollment target sits among peer trials
999 1st of 23 higher than 23 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
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