Clinical trial NCT06049797: A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
Official title: A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hot Flashes
Keywords: fezolinetant
vasomotor symptoms
menopause
night sweats
non-hormonal treatment
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2023-09-22
Enrollment: 1003
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants experiencing bothersome VMS with a confirmed diagnosis of VMS by an HCP and newly prescribed non-hormonal therapy (non-HT).

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Participant is diagnosed with bothersome VMS due to/associated with menopause for at least 3 months based on a standard of care assessment captured in consultation with an HCP including the participant's history, routine physical examination, and routine laboratory assessments.
* HCP has made the clinical decision to begin pharmacologic treatment with a non-HT including, a selective neurokinin 3 receptor (NK3-R) antagonist, an SSRI, SNRI, gabapentin, clonidine, pregabalin, oxybutynin or other non-HT, as part of the standard treatment for VMS. This may be the first course of treatment, a restart or a switch from one drug (HT/non- HT) to another non-HT. A restart or switch of a previous therapy requires a minimum of a 10-day period not on therapy/washout period prior to pre-baseline.
* Participant's health status is stable based on their medical history and general physical exam and determined to be a candidate for treatment with non-HTs.
* If participant has been prescribed an SSRI or SNRI for the treatment of depression or anxiety, they must be on a stable or consistent dose for a minimum of 3 months prior to screening.
* Participant has a negative urine pregnancy test at screening if not post-menopausal.
* Only for participants utilizing complementary and alternative therapies, mind-body techniques, or supplements for the treatment of VMS: participant has been on such therapies for ≥ 3 months prior to screening and intends to continue through duration of study.
* Confirmation has been made that the participant is able to obtain the prescribed non hormonal therapy (e.g., insurance coverage verified, participant has ability to self pay, or patient support program activated for at least 12 months for the uninsured participants, if applicable).

Exclusion Criteria:

* Participant is currently enrolled in any interventional or non-interventional wearable device study.
* Participant has any condition which makes the participant unsuitable for the study.
* Participant has a contraindication to the non-HT they are being prescribed for the treatment of VMS.
* Participant is currently taking hormonal contraceptives or other systemic HTs (including estrogen and/or progesterone, and/or testosterone preparations) and has not had a 10-day washout period prior to pre-baseline (vaginal/local estrogen preparations and levonorgestrel-releasing intrauterine system are not prohibited).
* Participant has presence of moderately severe or severe depression per standard of care assessment utilizing a standardized depression screening tool.
* Participant is currently pregnant or planning to become pregnant.
* Participant is post-menopausal and has a history of unexplained uterine bleeding within the last 6 months.
* Participant has pre-existing uncontrolled thyroid disease.
* Participant has unstable angina or participant has uncontrolled hypertension based on a standard of care assessment.

  * Participants who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.
  * Participants with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).
* Participant has had insomnia unrelated to either menopause or bothersome VMS due to/associated with menopause.
* Participant has known substance abuse or alcohol addiction within 6 months of screening.
* Participant has been on intramuscular estradiol within 8 weeks of screening.
* Participant has a current diagnosis of a malignancy or history of a malignancy within the past 2 years (This does not include basal cell carcinoma or breast cancer.)
* Participants with metastatic (Stage 4) breast cancer.
* Participants who have been prescribed adjuvant endocrine therapy (tamoxifen or aromatase inhibitors with or without gonadotropin-releasing hormone analogues) for their non-metastatic (stage 0 to 3) breast cancer but have not maintained a stable treatment regimen for at least 3 months prior to screening.
* Participant has initiated hormone pellet therapy within 6 months of screening.

Primary outcomes:
measure: Mean change from baseline to week 12 in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall VMS domain score
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Percentage of participants classified as 1-point responders as measured by the MENQol 1-week recall VMS domain
timeFrame: Up to week 52
measure: Percentage of participants classified as 2-point responders as measured by the MENQol 1-week recall VMS domain
timeFrame: Up to week 52
measure: Mean change from baseline in total score of Patient-Reported Outcomes Measurement Information System Sleep Disturbance Sexual Function (PROMIS SD SF) 8b
timeFrame: Baseline and weeks 4, 8, 12, 24 and 52
measure: Total score from Patient Global Impression of Severity (PGI-S) of SD
timeFrame: Up to week 52
measure: Total score from Patient Global Impression of Change (PGI-C) of SD
timeFrame: Up to week 52
measure: Change from baseline in average daily total sleep time, as recorded by wearable device
timeFrame: Baseline to weeks 4, 8 and 12
measure: Change from baseline in average daily sleep efficiency, as recorded by wearable device
timeFrame: Baseline to weeks 4, 8 and 12
measure: Change from baseline in average daily wake after sleep onset (WASO), as recorded by wearable device
timeFrame: Baseline to weeks 4, 8 and 12
measure: Change from baseline in average daily number of nighttime awakenings, as recorded by wearable device
timeFrame: Baseline to weeks 4, 8 and 12
measure: Change from baseline in average daily sleep latency, as recorded by wearable device
timeFrame: Baseline to weeks 4, 8 and 12
measure: Mean change from baseline in the MENQoL total score
timeFrame: Baseline to weeks 4, 8, 12, 24 and 52
measure: Mean change from baseline in the MENQoL vasomotor 1-week recall VMS domain score
timeFrame: Baseline to weeks 4, 8, 24 and 52
measure: Mean change from baseline in the MENQoL 1-week recall psychosocial domain score
timeFrame: Baseline to weeks 4, 8, 12, 24 and 52
measure: Mean change from baseline in the MENQoL 1-week recall physical domain score
timeFrame: Baseline to weeks 4, 8, 12, 24 and 52
measure: Mean change from baseline in the MENQoL 1-week recall sexual domain score
timeFrame: Baseline to weeks 4, 8, 12, 24 and 52
measure: Total score from PGI-C VMS
timeFrame: Up to week 52
measure: Mean change from baseline in the VMS-related work productivity and activity impairment (WPAI-VMS) domain score
timeFrame: Baseline to weeks 4, 8, 12, 24 and 52
measure: Mean change from baseline in the female sexual function index (FSFI) domain score
timeFrame: Baseline to weeks 4, 8, 12, 24 and 52
measure: Mean change from baseline in the mean number of moderate/severe VMS episodes per 24 hours self-reported by participants via an an eDiary
timeFrame: Baseline to weeks 4, 8 and 12
measure: Mean change from baseline in the mean number of daytime moderate/severe VMS episodes per 24 hours self-reported by participants via an eDiary
timeFrame: Baseline to weeks 4, 8 and 12
measure: Mean change from baseline in the mean number of nighttime moderate/severe VMS episodes per 24 hours self-reported by participants via an eDiary
timeFrame: Baseline to weeks 4, 8 and 12
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 52 weeks
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to 52 weeks
measure: Number of participants with vital sign abnormalities and/or adverse events (AEs)
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Birmingham
country: United States
facility: Accel Research Sites-Cahaba Medical Care-OBGYN
state: Alabama
city: Phoenix
country: United States
facility: Precision Trials AZ, LLC
state: Arizona
city: Lomita
country: United States
facility: Torrance Clinical Research Institute,Inc
state: California
city: Pomona
country: United States
facility: Dream Team Clinical Research
state: California
city: San Diego
country: United States
facility: Wake Research - Medical Center for Clinical Research WR-MCCR, LLC
state: California
city: Simi Valley
country: United States
facility: Millennium Clinical Trials LLC
state: California
city: Valley Village
country: United States
facility: Bayview Research Group, LLC
state: California
city: Aurora
country: United States
facility: University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus
state: Colorado
city: DeLand
country: United States
facility: Accel Research Sites
state: Florida
city: Doral
country: United States
facility: Nextlevel Research Center
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc. (WR-MSRA, LLC)
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC
state: Florida
city: Miami
country: United States
facility: Dr. Jarrett's Wellness Center
state: Florida
city: Ormond Beach
country: United States
facility: Complete Health Research
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, Llc
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Dunwoody
country: United States
facility: Alpha Clinical Research Georgia
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialists
state: Idaho
city: Chicago
country: United States
facility: Chicago Clinical Research Institute Inc.
state: Illinois
city: Brownsburg
country: United States
facility: Investigators Research Group, Llc
state: Indiana
city: Wichita
country: United States
facility: Tekton Research
state: Kansas
city: Marrero
country: United States
facility: Praetorian Pharmaceutical Research
state: Louisiana
city: Metairie
country: United States
facility: Southern Clinical Research Associates
state: Louisiana
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group, LLC
state: Michigan
city: Missoula
country: United States
facility: Montana Medical Research, Inc.
state: Montana
city: Albuquerque
country: United States
facility: Bosque Women's Care
state: New Mexico
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Charlotte
country: United States
facility: Premier Gynecology & Wellness
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research
state: North Carolina
city: Englewood
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Moore
country: United States
facility: Tekton Research
state: Oklahoma
city: Philadelphia
country: United States
facility: Clinical Research Of Philadelphia, Llc
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital / Tower Health
state: Pennsylvania
city: West Columbia
country: United States
facility: Biocentric Health Research
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, Llc
state: Tennessee
city: Fort Worth
country: United States
facility: Signature Gyn Services
state: Texas
city: Houston
country: United States
facility: UT Health Women's Research Center at Memorial City
state: Texas
city: Houston
country: United States
facility: TMC Life Research, Inc
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Research Center
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc
state: Texas
city: Plano
country: United States
facility: ClinRx Research LLC
state: Texas
city: San Antonio
country: United States
facility: DCT - Stone Oak, LLC dba Discovery Clinical Trials
state: Texas
city: Riverton
country: United States
facility: Granger Medical Clinic
state: Utah
city: Norfolk
country: United States
facility: Tidewater Physicians for Women
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research Inc
state: Virginia
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Central Contact
role: STUDY_DIRECTOR
References: