A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats (OPTION-VMS)
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| ClinicalTrials.gov Identifier: NCT06049797 |
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Recruitment Status :
Recruiting
First Posted : September 22, 2023
Last Update Posted : May 8, 2024
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Sponsor:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Hot Flashes | Drug: 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 |
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms |
| Actual Study Start Date : | November 15, 2023 |
| Estimated Primary Completion Date : | September 30, 2025 |
| Estimated Study Completion Date : | September 30, 2025 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Neurokinin 3 Receptor (NK3-R) Antagonist
Participants prescribed NK3-R Antagonist for the treatment of VMS.
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Drug: Fezolinetant
Oral
Other Names:
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Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI)
Participants prescribed SSRI/SNRI for the treatment of VMS.
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Drug: Paroxetine
Oral Drug: Citalopram Oral Drug: Escitalopram Oral Drug: Desvenlafaxine Oral Drug: Venlafaxine Oral Drug: Any other SSRI/SNRI not already specified Oral |
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Other
Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS.
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Drug: Gabapentin
Oral Drug: Clonidine Oral Drug: Pregabalin Oral Drug: Oxybutynin Oral Drug: Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category above Oral |
Primary Outcome Measures :
- 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 [ Time Frame: Baseline and week 12 ]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.
Secondary Outcome Measures :
- Percentage of participants classified as 1-point responders as measured by the MENQol 1-week recall VMS domain [ Time Frame: Up to week 52 ]Participants with a reduction (improvement) in symptom bother score ≥ 1 unit will be classified as 1-point responders.
- Percentage of participants classified as 2-point responders as measured by the MENQol 1-week recall VMS domain [ Time Frame: Up to week 52 ]Participants with a reduction (improvement) in symptom bother score ≥ 2 unit will be classified as 2-point responders.
- Mean change from baseline in total score of Patient-Reported Outcomes Measurement Information System Sleep Disturbance Sexual Function (PROMIS SD SF) 8b [ Time Frame: Baseline and weeks 4, 8, 12, 24 and 52 ]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).
- Total score from Patient Global Impression of Severity (PGI-S) of SD [ Time Frame: Up to week 52 ]The PGI-S SD evaluates patient perceived severity of sleep disturbance. Ratings range from (1) no problems to (4) severe problems.
- Total score from Patient Global Impression of Change (PGI-C) of SD [ Time Frame: Up to week 52 ]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.
- Change from baseline in average daily total sleep time, as recorded by wearable device [ Time Frame: Baseline to weeks 4, 8 and 12 ]The wearable device will capture movement and physiological signals to derive measures related to sleep.
- Change from baseline in average daily sleep efficiency, as recorded by wearable device [ Time Frame: Baseline to weeks 4, 8 and 12 ]The wearable device will capture movement and physiological signals to derive measures related to sleep.
- Change from baseline in average daily wake after sleep onset (WASO), as recorded by wearable device [ Time Frame: Baseline to weeks 4, 8 and 12 ]The wearable device will capture movement and physiological signals to derive measures related to sleep.
- Change from baseline in average daily number of nighttime awakenings, as recorded by wearable device [ Time Frame: Baseline to weeks 4, 8 and 12 ]The wearable device will capture movement and physiological signals to derive measures related to sleep.
- Change from baseline in average daily sleep latency, as recorded by wearable device [ Time Frame: Baseline to weeks 4, 8 and 12 ]The wearable device will capture movement and physiological signals to derive measures related to sleep.
- Mean change from baseline in the MENQoL total score [ Time Frame: Baseline to weeks 4, 8, 12, 24 and 52 ]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.
- Mean change from baseline in the MENQoL vasomotor 1-week recall VMS domain score [ Time Frame: Baseline to weeks 4, 8, 24 and 52 ]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.
- Mean change from baseline in the MENQoL 1-week recall psychosocial domain score [ Time Frame: Baseline to weeks 4, 8, 12, 24 and 52 ]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.
- Mean change from baseline in the MENQoL 1-week recall physical domain score [ Time Frame: Baseline to weeks 4, 8, 12, 24 and 52 ]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.
- Mean change from baseline in the MENQoL 1-week recall sexual domain score [ Time Frame: Baseline to weeks 4, 8, 12, 24 and 52 ]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.
- Total score from PGI-C VMS [ Time Frame: Up to week 52 ]PGI-C VMS evaluates participant perceived change in VMS. Ratings range from (1) much better to (7) much worse.
- Mean change from baseline in the VMS-related work productivity and activity impairment (WPAI-VMS) domain score [ Time Frame: Baseline to weeks 4, 8, 12, 24 and 52 ]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).
- Mean change from baseline in the female sexual function index (FSFI) domain score [ Time Frame: Baseline to weeks 4, 8, 12, 24 and 52 ]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.
- Mean change from baseline in the mean number of VMS episodes per 24 hours self-reported by participants via wearable device event marker [ Time Frame: Baseline to weeks 4, 8 and 12 ]Participant manually records VMS episodes on the wearable device.
- Mean change from baseline in the mean number of daytime VMS episodes per 24 hours self-reported by participants via wearable device event marker [ Time Frame: Baseline to weeks 4, 8 and 12 ]Participant manually records VMS episodes on the wearable device.
- Mean change from baseline in the mean number of nighttime VMS episodes per 24 hours self-reported by participants via wearable device event marker [ Time Frame: Baseline to weeks 4, 8 and 12 ]Participant manually records VMS episodes on the wearable device.
- Number of participants with Adverse Events (AEs) [ Time Frame: Up to 52 weeks ]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.
- Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 52 weeks ]
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.
- Number of participants with vital sign abnormalities and/or adverse events (AEs) [ Time Frame: Up to 52 weeks ]Number of participants with potentially clinically significant vital sign values.
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| Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| 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).
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 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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06049797
Contacts
| Contact: Astellas Pharma Global Development, Inc. | 800-888-7704 | Astellas.registration@astellas.com |
Locations
Show 40 study locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
| Study Director: | Central Contact | Astellas Pharma Global Development, Inc. |
| Responsible Party: | Astellas Pharma Global Development, Inc. |
| ClinicalTrials.gov Identifier: | NCT06049797 |
| Other Study ID Numbers: |
2693-MA-3457 |
| First Posted: | September 22, 2023 Key Record Dates |
| Last Update Posted: | May 8, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas." |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
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fezolinetant vasomotor symptoms menopause night sweats non-hormonal treatment |
Additional relevant MeSH terms:
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Hot Flashes Clonidine Pregabalin Gabapentin Citalopram Paroxetine Venlafaxine Hydrochloride Desvenlafaxine Succinate Oxybutynin Escitalopram Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents Selective Serotonin Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |