A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
Public ClinicalTrials.gov record NCT06049797. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06049797
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 999 participants
Conditions and interventions
Conditions
Interventions
- Fezolinetant Drug
- Paroxetine Drug
- Citalopram Drug
- Escitalopram Drug
- Desvenlafaxine Drug
- Venlafaxine Drug
- Gabapentin Drug
- Clonidine Drug
- Pregabalin Drug
- Oxybutynin Drug
- Any other SSRI/SNRI not already specified Drug
- Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category above Drug
Drug
Eligibility (public fields only)
- Age range
- 40 Years to 75 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 15, 2023 (Actual)
- Primary completion
- Sep 6, 2025 (Actual)
- Completion
- May 7, 2026 (Actual)
- Last update posted
- Jun 5, 2026
2023 – 2026
United States locations
- U.S. sites
- 48
- U.S. states
- 24
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35205 | — |
| Accel Research Sites-Cahaba Medical Care-OBGYN | Birmingham | Alabama | 35218 | — |
| Precision Trials AZ, LLC | Phoenix | Arizona | 85032 | — |
| Torrance Clinical Research Institute,Inc | Lomita | California | 90717 | — |
| Dream Team Clinical Research | Pomona | California | 91767 | — |
| Wake Research - Medical Center for Clinical Research WR-MCCR, LLC | San Diego | California | 92120 | — |
| Millennium Clinical Trials LLC | Simi Valley | California | 93065 | — |
| Bayview Research Group, LLC | Valley Village | California | 91607 | — |
| University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Accel Research Sites | DeLand | Florida | 32720 | — |
| Nextlevel Research Center | Doral | Florida | 33172 | — |
| Multi-Specialty Research Associates, Inc. (WR-MSRA, LLC) | Lake City | Florida | 32055 | — |
| Altus Research | Lake Worth | Florida | 33461 | — |
| Suncoast Research Associates, LLC | Miami | Florida | 33173 | — |
| Dr. Jarrett's Wellness Center | Miami | Florida | 33186 | — |
| Complete Health Research | Ormond Beach | Florida | 32174 | — |
| Comprehensive Clinical Trials, Llc | West Palm Beach | Florida | 33409 | — |
| Agile Clinical Research Trials, LLC | Atlanta | Georgia | 30342 | — |
| Alpha Clinical Research Georgia | Dunwoody | Georgia | 30350 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Rosemark Women Care Specialists | Idaho Falls | Idaho | 83404 | — |
| Chicago Clinical Research Institute Inc. | Chicago | Illinois | 60607 | — |
| Investigators Research Group, Llc | Brownsburg | Indiana | 46112 | — |
| Praetorian Pharmaceutical Research | Marrero | Louisiana | 70072 | — |
| Southern Clinical Research Associates | Metairie | Louisiana | 70001 | — |
| Saginaw Valley Medical Research Group, LLC | Saginaw | Michigan | 48604 | — |
| Montana Medical Research, Inc. | Missoula | Montana | 59808 | — |
| Bosque Women's Care | Albuquerque | New Mexico | 87109 | — |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | — |
| Premier Gynecology & Wellness | Charlotte | North Carolina | 28207 | — |
| Eastern Carolina Women's Center | New Bern | North Carolina | 28562 | — |
| Unified Women's Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| HWC Women's Research Center | Englewood | Ohio | 45322 | — |
| Tekton Research | Moore | Oklahoma | 73160 | — |
| Clinical Research Of Philadelphia, Llc | Philadelphia | Pennsylvania | 19114 | — |
| Reading Hospital / Tower Health | West Reading | Pennsylvania | 19611 | — |
| Biocentric Health Research | West Columbia | South Carolina | 29169 | — |
| Chattanooga Medical Research, Llc | Chattanooga | Tennessee | 37404 | — |
| Signature Gyn Services | Fort Worth | Texas | 76104 | — |
| UT Health Women's Research Center at Memorial City | Houston | Texas | 77024 | — |
| TMC Life Research, Inc | Houston | Texas | 77054 | — |
| Biopharma Informatic Research Center | Houston | Texas | 77084 | — |
| Pioneer Research Solutions, Inc | Houston | Texas | 77099 | — |
| ClinRx Research LLC | Plano | Texas | 75024 | — |
| DCT - Stone Oak, LLC dba Discovery Clinical Trials | San Antonio | Texas | 78258 | — |
| Granger Medical Clinic | Riverton | Utah | 84065 | — |
| Tidewater Physicians for Women | Norfolk | Virginia | 23502 | — |
| Seattle Clinical Research Center | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06049797, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 5, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06049797 live on ClinicalTrials.gov.