A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats

Hot Flashes Clinical Trial

— OPTION-VMS  

Official title:

A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049797
• Other study ID #: 2693-MA-3457
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Astellas Pharma Inc
• Contact: Astellas Pharma Global Development, Inc.
• Phone: 800-888-7704
• Email: Astellas.registration[@]astellas.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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 hormonal therapies 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.

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• Fezolinetant
Oral
• Paroxetine
Oral
• Citalopram
Oral
• Escitalopram
Oral
• Desvenlafaxine
Oral
• Venlafaxine
Oral
• Gabapentin
Oral
• Clonidine
Oral
• Pregabalin
Oral
• Oxybutynin
Oral
• Any other SSRI/SNRI not already specified
Oral
• Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category above
Oral

Locations

Country	Name	City	State
United States	Bosque Women's Care	Albuquerque	New Mexico
United States	Institute for Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania
United States	Agile Clinical Research Trials, LLC	Atlanta	Georgia
United States	Tekton Research	Austin	Texas
United States	Accel Research Sites-Cahaba Medical Care-OBGYN	Birmingham	Alabama
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Premier Gynecology & Wellness	Charlotte	North Carolina
United States	Chattanooga Medical Research, Llc	Chattanooga	Tennessee
United States	Axia Women's Health - Seven Hills Women's Health Centers - Anderson	Cincinnati	Ohio
United States	Nextlevel Research Center	Doral	Florida
United States	Alpha Clinical Research Georgia	Dunwoody	Georgia
United States	Tekton Research	Edmond	Oklahoma
United States	HWC Women's Research Center	Englewood	Ohio
United States	Signature Gyn Services	Fort Worth	Texas
United States	Pioneer Research Solutions, Inc	Houston	Texas
United States	TMC Life Research, Inc	Houston	Texas
United States	Multi-Specialty Research Associates, Inc.	Lake City	Florida
United States	Altus Research	Lake Worth	Florida
United States	Torrance Clinical Research Institute,Inc	Lomita	California
United States	Praetorian Pharmaceutical Research	Marrero	Louisiana
United States	Dr. Jarrett's Wellness Center	Miami	Florida
United States	Suncoast Research Associates, LLC	Miami	Florida
United States	Montana Medical Research, Inc.	Missoula	Montana
United States	Tekton Research	Moore	Oklahoma
United States	Complete Health Research	Ormond Beach	Florida
United States	Clinical Research Of Philadelphia, Llc	Philadelphia	Pennsylvania
United States	Precision Trials AZ, LLC	Phoenix	Arizona
United States	Dream Team Clinical Research	Pomona	California
United States	Granger Medical Clinic	Riverton	Utah
United States	DCT - Stone Oak, LLC dba Discovery Clinical Trials	San Antonio	Texas
United States	Wake Research - Medical Center for Clinical Research WR-MCCR, LLC	San Diego	California
United States	Physician Care Clinical Research, LLC	Sarasota	Florida
United States	GCP Clinical Research	Tampa	Florida
United States	Tidewater Clinical Research Inc	Virginia Beach	Virginia
United States	Biocentric Health Research	West Columbia	South Carolina
United States	Comprehensive Clinical Trials, Llc	West Palm Beach	Florida
United States	Tekton Research	Wichita	Kansas
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	Unified Women's Clinical Research	Winston-Salem	North Carolina
United States	Tekton Research	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and week 12
Secondary	Percentage of participants classified as 1-point responders as measured by the MENQol 1-week recall VMS domain	Participants with a reduction (improvement) in symptom bother score = 1 unit will be classified as 1-point responders.	Up to week 52
Secondary	Percentage of participants classified as 2-point responders as measured by the MENQol 1-week recall VMS domain	Participants with a reduction (improvement) in symptom bother score = 2 unit will be classified as 2-point responders.	Up to week 52
Secondary	Mean change from baseline in total score of Patient-Reported Outcomes Measurement Information System Sleep Disturbance Sexual Function (PROMIS SD SF) 8b	The PROMIS SD SF 8b assesses self-reported sleep disturbance over the past 7 days and includes perceptions of restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. Responses to each of the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the concept measured (disturbed sleep).	Baseline and weeks 4, 8, 12, 24 and 52
Secondary	Total score from Patient Global Impression of Severity (PGI-S) of SD	The PGI-S SD evaluates patient perceived severity of sleep disturbance. Ratings range from (1) no problems to (4) severe problems.	Up to week 52
Secondary	Total score from Patient Global Impression of Change (PGI-C) of SD	PGI-C SD evaluates patient perceived change in sleep disturbance from the initiation of treatment. Ratings range from (1) much better to (7) much worse.	Up to week 52
Secondary	Change from baseline in average daily total sleep time, as recorded by wearable device	The wearable device will capture movement and physiological signals to derive measures related to sleep.	Baseline to weeks 4, 8 and 12
Secondary	Change from baseline in average daily sleep efficiency, as recorded by wearable device	The wearable device will capture movement and physiological signals to derive measures related to sleep.	Baseline to weeks 4, 8 and 12
Secondary	Change from baseline in average daily wake after sleep onset (WASO), as recorded by wearable device	The wearable device will capture movement and physiological signals to derive measures related to sleep.	Baseline to weeks 4, 8 and 12
Secondary	Change from baseline in average daily number of nighttime awakenings, as recorded by wearable device	The wearable device will capture movement and physiological signals to derive measures related to sleep.	Baseline to weeks 4, 8 and 12
Secondary	Change from baseline in average daily sleep latency, as recorded by wearable device	The wearable device will capture movement and physiological signals to derive measures related to sleep.	Baseline to weeks 4, 8 and 12
Secondary	Mean change from baseline in the MENQoL total score	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. The total score is the mean of the domain means. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL.	Baseline to weeks 4, 8, 12, 24 and 52
Secondary	Mean change from baseline in the MENQoL vasomotor 1-week recall VMS domain score	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.	Baseline to weeks 4, 8, 24 and 52
Secondary	Mean change from baseline in the MENQoL 1-week recall psychosocial domain score	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.	Baseline to weeks 4, 8, 12, 24 and 52
Secondary	Mean change from baseline in the MENQoL 1-week recall physical domain score	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.	Baseline to weeks 4, 8, 12, 24 and 52
Secondary	Mean change from baseline in the MENQoL 1-week recall sexual domain score	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.	Baseline to weeks 4, 8, 12, 24 and 52
Secondary	Total score from PGI-C VMS	PGI-C VMS evaluates participant perceived change in VMS. Ratings range from (1) much better to (7) much worse.	Up to week 52
Secondary	Mean change from baseline in the VMS-related work productivity and activity impairment (WPAI-VMS) domain score	The WPAI-VMS is a 6-item PRO measure that examines VMS-related work productivity and activity in the preceding 7 days. It consists of 4 domains: absenteeism, presenteeism, overall work productivity loss, and activity impairment. WPAI-VMS outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity (that is, worse outcomes).	Baseline to weeks 4, 8, 12, 24 and 52
Secondary	Mean change from baseline in the female sexual function index (FSFI) domain score	The FSFI is comprised of 19 questions with response options varying among items and ranging from 0 to 5 or 1 to 5. The FSFI has 6 domains: desire, arousal, lubrication, orgasm, satisfaction and pain. Within the individual domains, a domain score of zero indicates that the participant-reported having no sexual activity during the past month. The overall score can range from 2 to 36. A higher score overall or for individual domains indicates better sexual function.	Baseline to weeks 4, 8, 12, 24 and 52
Secondary	Mean change from baseline in the mean number of VMS episodes per 24 hours self-reported by participants via wearable device event marker	Participant manually records VMS episodes on the wearable device.	Baseline to weeks 4, 8 and 12
Secondary	Mean change from baseline in the mean number of daytime VMS episodes per 24 hours self-reported by participants via wearable device event marker	Participant manually records VMS episodes on the wearable device.	Baseline to weeks 4, 8 and 12
Secondary	Mean change from baseline in the mean number of nighttime VMS episodes per 24 hours self-reported by participants via wearable device event marker	Participant manually records VMS episodes on the wearable device.	Baseline to weeks 4, 8 and 12
Secondary	Number of participants with Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal (investigational) product.	Up to 52 weeks
Secondary	Number of participants with Serious Adverse Events (SAEs)	An AE is considered "serious" if, in the view of either the investigator or sponsor, it: Results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, is a congenital anomaly or birth defect of a child conceived during the exposure of one of the parents to the drug studied, requires inpatient hospitalization or leads to prolongation of hospitalization, is a medically important event or reaction.	Up to 52 weeks
Secondary	Number of participants with vital sign abnormalities and/or adverse events (AEs)	Number of participants with potentially clinically significant vital sign values.	Up to 52 weeks