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A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
NCT06049797 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 999 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06049797 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06049797?
The interventions under investigation include: Escitalopram (DRUG), Fezolinetant (DRUG), Paroxetine (DRUG), Citalopram (DRUG), Desvenlafaxine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06049797?
This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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