A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)


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  • Incidence and severity of Treatment Emergent Adverse Events [ Time Frame: Baseline through Week 15 ]

    Incidence and severity of Treatment Emergent Adverse Events

  • Physical examination [ Time Frame: Baseline, Week 12, and Week 15 ]

    The physical examination includes height (at screening only), weight, and waist circumference

  • Assessment of Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, Week 12, and Week 15 ]

    Change in patient reported outcome C-SSRS

  • Assessment of vital signs [ Time Frame: Baseline through Week 15 ]

    Assessment of sitting systolic and diastolic blood pressure and pulse rate

  • Assessment of electrocardiogram (ECG) parameters [ Time Frame: Baseline through Week 15 ]

    Assessment of 12-lead ECG parameters

  • Assessment of clinical laboratory changes [ Time Frame: Baseline through Week 15 ]

    Assessment of hematology, biochemistry, urinalysis, and coagulation laboratory tests

  • Assessment of endometrial health [ Time Frame: Baseline and Week 12 ]

    Assessment of endometrial health as found with transvaginal ultrasound, possibly with endometrial biopsy

  • Assessment of plasma bone density marker concentrations [ Time Frame: Baseline through Week 15 ]

    Assessment of plasma bone alkaline phosphatase (BALB), procollagen type 1 amino-terminal propeptide (P1NP), and carboxy-terminal telopeptide of type I collagen (CTX)

  • Change in the mean number of vasomotor symptoms (mild, moderate, and severe) per day [ Time Frame: Baseline and each week through Week 12 ]

    Change in the mean number of vasomotor symptoms (mild, moderate, and severe) as recorded twice daily by patient in ePRO diary

  • Change in the mean number of vasomotor symptoms (moderate and severe) per day [ Time Frame: Baseline and each week through Week 12 ]

    Change in the mean number of vasomotor symptoms (moderate and severe) as recorded twice daily by patient in ePRO diary

  • Change in the mean severity of vasomotor symptoms (mild, moderate, and severe) per day [ Time Frame: Baseline and each week through Week 12 ]

    Change in the mean severity of vasomotor symptoms (mild, moderate, and severe) as recorded twice daily by patient in ePRO diary

  • Change in the mean severity of vasomotor symptoms (moderate and severe) per day [ Time Frame: Baseline and each week through Week 12 ]

    Change in the mean severity of vasomotor symptoms (moderate and severe) as recorded twice daily by patient in ePRO diary

  • Change in the mean hot flash score per day of vasomotor symptoms (mild, moderate, and severe) [ Time Frame: Baseline and each week through Week 12 ]

    Change in the mean hot flash score per day of vasomotor symptoms (mild, moderate, and severe) as recorded twice daily by patient in ePRO diary

  • Change in the mean hot flash score per day of vasomotor symptoms (moderate and severe) [ Time Frame: Baseline and each week through Week 12 ]

    Change in the mean hot flash score per day of vasomotor symptoms (moderate and severe) as recorded twice daily by patient in ePRO diary

  • Percent reduction in the mean number of mild, moderate, and severe vasomotor symptoms per day [ Time Frame: Baseline and each week through Week 12 ]

    Percent reduction in the mean number of mild, moderate, and severe vasomotor symptoms per day as recorded twice daily by patient in ePRO diary

  • Percent reduction in the mean number of moderate and severe vasomotor symptoms per day [ Time Frame: Baseline and each week through Week 12 ]

    Percent reduction in the mean number of moderate and severe vasomotor symptoms per day as recorded twice daily by patient in ePRO diary

  • Achievement of 50%, 70%, 90%, and 100% in the mean number of mild, moderate, and severe vasomotor symptoms per day [ Time Frame: Baseline and each week through Week 12 ]

    Achievement of 50%, 70%, 90%, and 100% in the mean number of mild, moderate, and severe vasomotor symptoms per day as recorded twice daily by patient in ePRO diary

  • Achievement of 50%, 70%, 90%, and 100% in the mean number of moderate and severe vasomotor symptoms per day [ Time Frame: Baseline and each week through Week 12 ]

    Achievement of 50%, 70%, 90%, and 100% in the mean number of moderate and severe vasomotor symptoms per day as recorded twice daily by patient in ePRO diary

  • Achievement of absolute reduction of 2, 3, 4, and 5 in the mean number of mild, moderate, and severe vasomotor symptoms per day [ Time Frame: Baseline and each week through Week 12 ]

    Achievement of absolute reduction of 2, 3, 4, and 5 in the mean number of mild, moderate, and severe vasomotor symptoms per day as recorded twice daily by patient in ePRO diary

  • Achievement of absolute reduction of 2, 3, 4, and 5 in the mean number of moderate and severe vasomotor symptoms per day [ Time Frame: Baseline and each week through Week 12 ]

    Achievement of absolute reduction of 2, 3, 4, and 5 in the mean number of moderate and severe vasomotor symptoms per day as recorded twice daily by patient in electronic Patient Reported Outcome (ePRO) diary

  • Change in patient reported outcome Hot Flash Related Daily Interference Scale (HFRDIS) per visit [ Time Frame: Baseline, Week 4, Week 8, Week 12, and Week 15 ]

    Change in patient reported outcome HFRDIS completed by patient at each visit

  • Change in patient reported outcome Leeps Sleep Evaluation Questionnaire (LSEQ) per visit [ Time Frame: Baseline, Week 4, Week 8, Week 12, and Week 15 ]

    Change in patient reported outcomes LSEQ completed by patient at each visit

  • Change in patient reported outcome Greene Climacteric Scale (GCS) per visit [ Time Frame: Baseline, Week 4, Week 8, Week 12, and Week 15 ]

    Change in patient reported outcome GCS completed by patient at each visit

  • Change in patient reported outcome Menopause-Specific Quality of Life (MENQoL) per visit [ Time Frame: Baseline, Week 4, Week 8, Week 12, and Week 15 ]

    Change in patient reported outcome MENQoL completed by patient at each visit