A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 999
- 试验地点
- 95
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Other
Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS.
干预措施: Clonidine (Drug)
Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI)
Participants prescribed SSRI/SNRI for the treatment of VMS.
干预措施: Any other SSRI/SNRI not already specified (Drug)
Other
Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS.
干预措施: Gabapentin (Drug)
Neurokinin 3 Receptor (NK3-R) Antagonist
Participants prescribed NK3-R Antagonist for the treatment of VMS.
干预措施: Fezolinetant (Drug)
Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI)
Participants prescribed SSRI/SNRI for the treatment of VMS.
干预措施: Paroxetine (Drug)
Other
Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS.
干预措施: Pregabalin (Drug)
Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI)
Participants prescribed SSRI/SNRI for the treatment of VMS.
干预措施: Venlafaxine (Drug)
Other
Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS.
干预措施: Oxybutynin (Drug)
Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI)
Participants prescribed SSRI/SNRI for the treatment of VMS.
干预措施: Citalopram (Drug)
Other
Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS.
干预措施: Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category above (Drug)
Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI)
Participants prescribed SSRI/SNRI for the treatment of VMS.
干预措施: Desvenlafaxine (Drug)
Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI)
Participants prescribed SSRI/SNRI for the treatment of VMS.
干预措施: Escitalopram (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- Mean change from baseline in total score of Patient-Reported Outcomes Measurement Information System Sleep Disturbance Sexual Function (PROMIS SD SF) 8b(Baseline and weeks 4, 8, 12, 24 and 52)
- Total score from Patient Global Impression of Change (PGI-C) of SD(Up to week 52)
- Change from baseline in average daily sleep efficiency, as recorded by wearable device(Baseline to weeks 4, 8 and 12)
- Percentage of participants classified as 2-point responders as measured by the MENQol 1-week recall VMS domain(Up to week 52)
- Mean change from baseline in the MENQoL total score(Baseline to weeks 4, 8, 12, 24 and 52)
- Mean change from baseline in the MENQoL 1-week recall psychosocial domain score(Baseline to weeks 4, 8, 12, 24 and 52)
- Mean change from baseline in the MENQoL 1-week recall physical domain score(Baseline to weeks 4, 8, 12, 24 and 52)
- Percentage of participants classified as 1-point responders as measured by the MENQol 1-week recall VMS domain(Up to week 52)
- Total score from Patient Global Impression of Severity (PGI-S) of SD(Up to week 52)
- Change from baseline in average daily total sleep time, as recorded by wearable device(Baseline to weeks 4, 8 and 12)
- Change from baseline in average daily wake after sleep onset (WASO), as recorded by wearable device(Baseline to weeks 4, 8 and 12)
- Change from baseline in average daily number of nighttime awakenings, as recorded by wearable device(Baseline to weeks 4, 8 and 12)
- Change from baseline in average daily sleep latency, as recorded by wearable device(Baseline to weeks 4, 8 and 12)
- Mean change from baseline in the MENQoL vasomotor 1-week recall VMS domain score(Baseline to weeks 4, 8, 24 and 52)
- Mean change from baseline in the female sexual function index (FSFI) domain score(Baseline to weeks 4, 8, 12, 24 and 52)
- Mean change from baseline in the mean number of nighttime moderate/severe VMS episodes per 24 hours self-reported by participants via an eDiary(Baseline to weeks 4, 8 and 12)
- Mean change from baseline in the MENQoL 1-week recall sexual domain score(Baseline to weeks 4, 8, 12, 24 and 52)
- Total score from PGI-C VMS(Up to week 52)
- Mean change from baseline in the VMS-related work productivity and activity impairment (WPAI-VMS) domain score(Baseline to weeks 4, 8, 12, 24 and 52)
- Mean change from baseline in the mean number of moderate/severe VMS episodes per 24 hours self-reported by participants via an an eDiary(Baseline to weeks 4, 8 and 12)
- Mean change from baseline in the mean number of daytime moderate/severe VMS episodes per 24 hours self-reported by participants via an eDiary(Baseline to weeks 4, 8 and 12)
- Number of participants with Adverse Events (AEs)(Up to 52 weeks)
- Number of participants with Serious Adverse Events (SAEs)(Up to 52 weeks)
- Number of participants with vital sign abnormalities and/or adverse events (AEs)(Up to 52 weeks)