Clinical Trial Radar

Socio-demographic characteristics

Day 1

Menopausal status

Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early/premature menopause.

Day 1

Time since menopause onset and time since onset of menopausal symptoms

Day 1

Descriptive analyses of prior vasomotor symptoms (VMS) related clinical history

Day 1

Menopausal symptoms measured by MENQOL

MENQOL: Menopause-Specific Quality of Life Questionnaire. It contains 29 items questionnaire that assess presence of menopausal symptoms and how bothersome they are, across four domains: vasomotor, psychosocial, physical and sexual. For each item, the participant indicates if they have experienced the symptom (yes/no). If participants select yes, participants rate how bothered they were by the symptom using a scale with response options ranging from 0 'not at all bothered' to 6 'extremely bothered'. Based on the individual responses, item scores, domain scores, and a total MENQOL score are calculated. Each score ranges from 1-8, higher scores indicate greater bother.

Day 1, week 4,12 and when applicable at week 24, 52, 104

Height

Day 1, week 4 and week 12

Weight

Day 1, week 4 and week 12

Change in VMS from the baseline period to week 4 and 12

Baseline period: Time prior to first dose of elizanetant

Week 4 and 12

Change in sleep disturbances measured by PROMIS-SD-SF-8b questionnaire

PROMIS-SD-SF-8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b. It includes 8 items that assess self-reported sleep quality and sleep difficulties. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Four of the items are scored reversely. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.

Week 4, 12 and when applicable week 24, 52 and 104

Number of SAE and serious TEAE

From Day 1 to week 12 or week 104 when applicable

HCP reasons for prescribing elinzanetant

HCP: Health care professionals.

Day 1

Participants' satisfaction with treatment for symptoms associated with menopause

Measured by Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ). The MS-TSQ comprises 8 items and assesses satisfaction over the past four weeks to evaluate treatment satisfaction related to menopausal symptoms. Items are scored 1-5 on a Likert scale where 1 = very dissatisfied/not at all and 5 = very satisfied/very much

Week 12 and week 52 when applicable

Reasons for initiation, discontinuation or switching of elizanetant

Week 4, week 12 and when applicable week 52

Amount of elizanetant prescribed

Week 4, week 12 and when applicable week 52

Number of missed doses

Week 4, week 12 and when applicable week 52

Reasons for missed doses

Week 4, week 12 and when applicable week 52

Change in menopauase-related QoL

Measured by Menopause-Specific Quality of Life Questionnaire (MENQOL)

Day 1 to week 4, 12 and when applicable week 24, 52 and 104

Change in participant's affect

Measured by Positive and Negative Affect Schedule - Short Form (PANAS-SF). PANAS-SF Comprises 10 items evaluating how frequently individuals experience positive and negative affect. Items are scored in a 1-5 Likert scale where 1 = Very slightly or not at all and 5 = Extremely.

From week 1 to week 4, 12 and when applicable to week 24, 52 and 104

Change in work productivity and daily activity impairment

Measured by menopause-related Work Productivity and Activity Impairment (WPAI: Menopause). WPAI: Menopuase consists of 6 items assessing employment status, work hours, absenteeism, presenteeism (on-the-job productivity), and the impact of menopausal symptoms on both work and nonwork daily activities. Items are scored as yes/no or ranked from 0 "no effect" to 10 "completely affected".

From day 1 to week 4, 12 and when applicable to week 24, 52 and 104