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A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

14C ASP0367 In Males Study | Astellas Clinical Trials

A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab Study | Astellas Clinical Trials

A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

A study of ASP2138 in adults with stomach cancer or pancreatic cancer

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

A Study to Assess the Efficacy and Safety of IMAB362 in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Macular Degenerative Disease Study | Astellas Clinical Trials

A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

Study of ASP0739 Alone and with Pembrolizumab in Advanced Solid Tumors with NY-ESO-1 Expression Participants

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

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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."

Grouping is based on Peri-menopausal woman

Grouping is based on Post-menopausal woman

Grouping is based on Peri-menopausal woman with moderate-to-severe vasomotor symptoms (MR-VMS)

Grouping is based on Post-menopausal woman with moderate-to-severe vasomotor symptoms (MR-VMS)

Redacted CSR Synopsis English

This study is an online survey of women in and around menopause with moderate to severe hot flashes.  Menopause, a normal part of life, is a time after a woman's last period.  Hot flashes often occur during menopause.  They can disrupt a woman's daily life.

This study is about collecting information only.  There will be no treatment in this study.

This study will provide information about how many women have moderate to severe hot flashes in menopause.  It will also provide details on women's experiences with hot flashes.

Women from Brazil, Canada, Nordic Europe, and Mexico will take part in this study.  The women in this study will already be taking part in consumer panels.  Women will be contacted based on their age.  They will be asked if they would like to take part in this study.

Firstly, the women will answer questions about whether they are in menopause or are getting close to menopause.  They will also be asked how severe their hot flashes are.

From their answers, some women will be asked to complete an online survey.  These will be women who are in menopause and have moderate to severe hot flashes.  They will provide more details about how hot flashes have impacted their lives.  Also, they will answer questions on how hot flashes affect their quality of life.  Finally, they will answer questions about their experiences when they visited their doctor about their hot flashes.

A survey about hot flashes in women going through the menopause

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This is a cross-sectional non-product related survey including peri- and post-menopausal women with moderate to severe VMS associated with menopause.

Link to results and other applicable study documents on the Astellas Clinical Trials website

IQVIA

Prospective Survey of Women with Vasomotor Symptoms Associated with Menopause in Nordic Europe, Canada, Brazil and Mexico - WARM Study

Prevalence of moderate to severe VMS in post-menopausal women.  Post-menopause is defined as at least 12 consecutive months without a period.  Moderate VMS associated with menopause symptoms is defined as sensations of heat with sweating but being able to continue activities.  Severe VMS associated with menopause is defined as feelings of intense heat with sweating causing cessation of activities.  The recall period is 1 month prior to survey.

MENQoL measures the overall score and four domain-specific scores assessing wellbeing (vasomotor; psychosocial; physical; sexual).  Scores range from 1 to 8 with a higher score indicating worsening/increasing bothersomeness by the symptom experience.  The MENQoL recall period is 7 days prior to survey.

The WPAI-VMS questionnaire measures four domain specific scores assessing work productivity and activity impairment over the previous week (absenteeism; presenteeism; mean work productivity; activity impairment).  Scores range from 0 to 100%.  The four scores were expressed as impairment percentages with a higher score indicating less productivity and greater activity impairment. The WPAI recall period is 7 days prior to survey.

The PROMIS Sleep Disturbance instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Each item on the measure is rated on a 5-point scale with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. The PROMIS recall period is 7 days prior to survey.
(Only implemented in Canada, Brazil and Denmark).

The type of specialists reported by peri- and post-menopausal women will be assessed.

The types of over the counter treatment taken by peri- and post-menopausal women for MR symptoms will be assessed.

Average out-of-pocket expenses incurred in the treatment of menopause reported by medications bought will be assessed.

Percentage of peri- and post-menopausal women who seek help from Health Care Professionals (HCPs) for their MR-VMS.  Help from an HCP can be in the form of advice or receipt of pharmaceutical treatment.

Participants' attitudes towards their VMS will be evaluated using the following: agreement or disagreement to statements on menopause itself, available treatments, and willingness/aversion to hormone replacement therapy (HRT).

The number of peri- and post-menopausal women treated with hormonal treatment, non-hormonal treatment, or other approaches will be summarized.

The length of time on hormonal treatment in peri- and post-menopausal women will be summarized.