Hot Flashes
Conditions
Keywords
Hot flashes, ESN364, ASP2693, fezolinetant, menopause, postmenopausal
Brief summary
The primary purpose of this study was to evaluate the effect of ESN364 on the severity and frequency of hot flashes in early postmenopausal women suffering from hot flashes, in terms of changes in weekly Hot Flash Score from baseline to Week 12. This study also evaluated the effect of ESN364 on the severity and frequency of hot flashes at additional timepoints; hot flash interference on daily life, in terms of changes from baseline over time in Hot Flash Related Daily Interference Scale (HFRDIS); the effect of ESN364 on climacteric symptoms, in terms of changes from baseline over time in Leeds Sleep Evaluation Questionnaire (LSEQ), Greene Climacteric Scale (GCS), and Sheehan Disability Scale (SDS); pharmacodynamic (PD) effect; and safety and tolerability.
Interventions
DRUGFezolinetant
Oral Capsule
DRUGPlacebo
Oral Capsule
Sponsors
Ogeda S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Spontaneous amenorrhea for at least 12 consecutive months; or spontaneous amenorrhea for at least 6 months with biochemical criteria of menopause (FSH \>40 IU/L); or spontaneous amenorrhea for at least 3 months with biochemical/physical criteria of menopause (FSH \>40 IU/L and E2 \<0.21 nmol/); or having had bilateral oophorectomy at least 6 weeks prior to screening (with or without hysterectomy); * At least 49 moderate or severe hot flashes or night sweats over a period of 7 consecutive days, as recorded in the daily diary during the screening period, with at least 4 of those days with 7 or more moderate or severe hot flashes per day; * In good general health as determined on the basis of medical history and general physical examination performed at screening; hematology and chemistry parameters, pulse rate and/or blood pressure, and ECG within the reference range for the population studied, or showing no clinically relevant deviations; * Negative urine test for selected drugs of abuse (amphetamines, tricyclic antidepressants, cannabinoids, cocaine, tetrahydrocannabinol, or opiates) at screening; * Negative serology panel (including hepatitis B surface antigen \[HBsAg\], antihepatitis C virus \[HCV\] and human immunodeficiency virus (HIV) antibody screens); * Negative urine pregnancy test at screening;
Exclusion criteria
* Use of a prohibited therapy or not willing to wash-out drugs considered prohibited therapies; * History (in the past year) or presence of drug or alcohol abuse; * Suicide attempt in the past 3 years; * Previous or current history of a malignant tumor (except basal cell carcinoma); * Active liver disease or jaundice, or out-of-range values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST); or total bilirubin \>1.3 times the upper limit of normal (ULN); or creatinine \>1.5 times the ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula \<60 mL/min/1.73 m2 at screening; * Medical condition or chronic disease (including history of neurological \[including cognitive\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary \[e.g., moderate asthma\], or endocrine disease) or malignancy that could confound interpretation of the study outcome; * Any psychological disorder according to the criteria indicated in the Diagnostics and Statistical Manual of Mental Disorders (DSM, 4th edition) within one year prior to screening. Such disorders include but are not limited to current major depression, alcohol (more than 3 glasses of wine, beer, or equivalent/day) or substance abuse/dependence; * Unsuited to participate in the study, based on findings observed during physical examination, vital sign assessment, or 12-lead ECG; * History of severe allergy, hypersensitivity, or intolerance to drugs in general, including the study drug and any of its excipients; * Presence or sequellae of gastrointestinal, liver, kidney or other conditions known to interfere with the absorption, distribution, metabolism, or excretion (ADME) mechanisms of drugs; * Concurrent participation in another interventional study (or participation within 3 months prior to screening in this study); * History of poor compliance in clinical studies; * Unable or unwilling to complete the study procedures; * Subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof who is directly involved in the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in The Weekly General Hot Flash Score | Baseline and week 12 | The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HFs is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant dependent for both number and severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2) | Baseline and weeks 4, 8 and 12 | The HF Severity Score by method 2 takes into account moderate and severe HF during a given time period and was calculated as follows HF Severity score = \[(number of moderate HF/day × 2) + (number of severe HF/day × 3)\] The severity of HFs was clinically defined as follows: * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity. |
| Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12 | Baseline and weeks 4, 8 and 12 | The weekly HF frequency was calculated as number of mild, moderate and severe hot flashes over the week. * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of hot flashes is worse. |
| Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Baseline and weeks 4, 8 and 12 | The weekly HF frequency of moderate and severe HF was calculated as number of moderate and severe HF over the week. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of HF indicates worse symptoms. |
| Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Baseline and weeks 4, 8 and 12 | The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HFs is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity. |
| Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Baseline and weeks 4, 8 and 12 | The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HFs is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity. |
| Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Baseline and weeks 4, 8 and 12 | The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HF is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity. |
| Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH) | Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15) | Change From baseline in plasma concentration of FSH was reported. |
| Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Baseline and weeks 4, 8 and 12 | The weekly HF frequency of moderate and severe HF was calculated as number of moderate and severe HF over the week. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of HF indicates worse symptoms. |
| Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Baseline and weeks 4, 8 and 12 | The weekly HF frequency of moderate and severe HF was calculated as number of moderate and severe HF over the week. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of HF indicates worse symptoms. |
| Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Baseline and weeks 4, 8 and 12 | The HFRDIS was a 10-item scale which measured a woman's perceptions of the degree to which HF interfere with 9 daily life activities (work, social activities, leisure, sleep, mood, concentration, relations with others, sexuality, enjoying life); the 10th item measures interference with overall quality of life. This scale was modeled after items on the Brief Pain Inventory and Brief Fatigue Inventory both of which assessed the extent to which pain or fatigue interfere with daily life. Participants were asked to rate the extent to which HF had interfered with each item during the previous 4-week time interval using a 0 (do not interfere) to 10 (completely interfere) scale. Overall mean score was calculated as sum of items/number of available items. Higher score indicate a higher interference. |
| Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Baseline and weeks 4, 8 and 12 | The LSEQ was a 10-item self-rated questionnaire which assessed participants aspects of sleep and early morning behavior. The questions were grouped into 4 chronological areas: the ease of getting to sleep, the perceived quality of sleep, the ease of awaking from sleep, and the integrity of early morning behavior following wakefulness. The LSEQ was a visual analogue scale which requires respondents to place marks on a group of 10 cm lines. representing the changes they have experienced in a variety of symptoms since the beginning of treatment. Lines extends between extremes like more difficult than usual and easier than usual. Responses are measured using a 100-mm scale and are averaged to provide a score for each domain. |
| Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Baseline and weeks 4, 8 and 12 | The GCS was a 21-item scale which provides a brief but comprehensive and valid measure of climacteric symptomatology. Each item was rated by the participant according to its severity using a four-point rating scale from 0 (none) to 3 (severe). The first 20 items of the scale combine into three main independent symptom measures: psychological symptoms (items 1 to 11; score 0 to 33), physical symptoms (items 12 to 18; score 0 to 21), and vasomotor symptoms (items 19 to 20; score 0 to 6), by summing up the individual item scores. Item 21 is a probe for sexual dysfunction (Loss of interest in sex). The total score ranges from 0 to 63. Higher scores indicate worse symptoms. |
| Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1) | Baseline and weeks 4, 8 and 12 | The HF Severity Score by method 1 takes into account the number and severity of moderate and severe HF occurred during a given time period and was calculated as follows HF Severity score = \[(number of moderate HF/day × 2) + (number of severe HF/day × 3)\]/(number of moderate HF + number of severe HF) The severity of HFs was clinically defined as follows: * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity. |
| Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Baseline and weeks 4, 8 and 12 | The SDS was a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in a participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his/her 1- work/school, 2- social life, and 3- family life are impaired by his/her symptoms. In addition to the 3 items, the participants were asked two questions Days Lost: On how many days in the last week did your symptoms cause you to miss school or work or leave you unable to carry out your normal daily responsibilities? Day Unproductive: On how many days in the last week did you feel so impaired by your symptoms, that even though you went to school or work, your productivity was reduced? |
| Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH) | Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12: 3h, follow-up (week 15) | Change From baseline in plasma concentration of LH was reported. |
| Change From Baseline in Plasma Concentration of Estradiol (E2) | Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15) | Change From baseline in plasma concentration of E2 was reported. |
| Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG) | Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15) | Change From baseline in plasma concentration of SHBG was reported. |
| Change From Baseline in Plasma Concentration of Leptin | Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15) | Change From baseline in plasma concentration of leptin was reported. |
| Change From Baseline in Plasma Concentration of Insulin | Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15) | Change From baseline in plasma concentration of insulin was reported. |
| Change From Baseline in Plasma Concentration of C-peptide | Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15) | Change From baseline in plasma concentration of C-peptide was reported. |
| Change From Baseline in Plasma Concentration of Glycated Hemoglobin (HBA1c) | Baseline and week 12 | Change From baseline in plasma concentration of HBA1C was reported. |
| Number of Participants With Adverse Events (AE's) | From first dose of study drug until end of the study (Up to week 15) | An AE is any untoward medical occurrence in a participant administered a study drug, & which does not necessarily have to have a causal relationship with treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with use of a medicinal product (mp) whether or not considered related to the mp. An AE is considered serious if 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, results in congenital anomaly or birth defect, requires inparticipant hospitalization or leads to prolongation of hospitalization, hospitalization for treatment/observation/examination caused by AE is to be considered as serious, discontinuation due to increases in liver enzymes, other medically important events. TEAE was defined as an AE observed from first dose date up to end of study. |
| Change From Baseline in Plasma Concentration of Bone Alkaline Phosphatase (BALP) at Week 12 | Baseline and week 12 | Change from baseline in plasma concentration of BALP was reported. |
| Change From Baseline in Plasma Concentration of Carboxy-terminal Telopeptide of Type I Collagen (CTX) at Week 12 | Baseline and week 12 | Change from baseline in plasma concentration of CTX was reported. |
| Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Baseline and weeks 4, 8 and 12 | The SDS was a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in a participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his/her 1- work/school, 2- social life, and 3- family life are impaired by his/her symptoms on a 10-point visual analog scale. The 3 items could be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).Higher scores indicate significant functional impairment. |
Countries
Belgium
Participant flow
Recruitment details
Postmenopausal women participants between 40 to 65 years of age who had hot flashes (HF) and who met the inclusion criteria and none of the exclusion criteria were enrolled in this study.
Pre-assignment details
Prior to randomization, participants had a screening period during which a minimum 7-day collection of baseline HF frequency and severity assessments were performed.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. | 44 |
| Fezolinetant Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks. | 43 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Miscellaneous | 1 | 1 |
| Overall Study | Participant Did not Fulfill all Inclusion/Exclusion Criteria | 1 | 0 |
| Overall Study | Serious Adverse Event | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Fezolinetant |
|---|---|---|---|
| Age, Continuous | 53.7 Years STANDARD_DEVIATION 4.25 | 53.5 Years STANDARD_DEVIATION 4.12 | 53.3 Years STANDARD_DEVIATION 4.03 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 84 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 44 Participants | 86 Participants | 42 Participants |
| Sex: Female, Male Female | 44 Participants | 87 Participants | 43 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weekly General Hot Flash Score | 25.76 Score on a scale STANDARD_DEVIATION 10.26 | 27.24 Score on a scale STANDARD_DEVIATION 11.93 | 28.76 Score on a scale STANDARD_DEVIATION 13.39 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 43 |
| other Total, other adverse events | 18 / 44 | 18 / 43 |
| serious Total, serious adverse events | 1 / 44 | 0 / 43 |
Outcome results
Primary
Change From Baseline to Week 12 in The Weekly General Hot Flash Score
The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HFs is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant dependent for both number and severity.
Time frame: Baseline and week 12
Population: Intent-to-treat (ITT) population (included all randomized participants who received at least one dose of the study medication and who had post-baseline efficacy data) with available data at specified time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Change From Baseline to Week 12 in The Weekly General Hot Flash Score | -12.19 score on a scale |
| Fezolinetant | Change From Baseline to Week 12 in The Weekly General Hot Flash Score | -26.51 score on a scale |
p-value: <0.00195% CI: [-16.89, -7.79]ANCOVA
Secondary
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
The GCS was a 21-item scale which provides a brief but comprehensive and valid measure of climacteric symptomatology. Each item was rated by the participant according to its severity using a four-point rating scale from 0 (none) to 3 (severe). The first 20 items of the scale combine into three main independent symptom measures: psychological symptoms (items 1 to 11; score 0 to 33), physical symptoms (items 12 to 18; score 0 to 21), and vasomotor symptoms (items 19 to 20; score 0 to 6), by summing up the individual item scores. Item 21 is a probe for sexual dysfunction (Loss of interest in sex). The total score ranges from 0 to 63. Higher scores indicate worse symptoms.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 8: Psychological | -2.6 score on a scale | Standard Deviation 5.31 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 12: Physical | -2.4 score on a scale | Standard Deviation 3.8 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 8: Loss of interest in Sex | -0.5 score on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 4: Vasomotor | -1.1 score on a scale | Standard Deviation 1.79 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 12: Psychological | -2.9 score on a scale | Standard Deviation 5.14 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 8: Vasomotor | -1.7 score on a scale | Standard Deviation 2.23 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 4: Psychological | -2.3 score on a scale | Standard Deviation 5.22 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 12: Vasomotor | -1.5 score on a scale | Standard Deviation 2.31 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 4: Physical | -2.1 score on a scale | Standard Deviation 3.68 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 4: Total Symptom Score | -5.5 score on a scale | Standard Deviation 9.33 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 12: Loss of Interest in Sex | -0.4 score on a scale | Standard Deviation 0.75 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 8: Total Symptom Score | -5.8 score on a scale | Standard Deviation 8.89 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 8: Physical | -1.9 score on a scale | Standard Deviation 3.46 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 12: Total Symptom Score | -6.3 score on a scale | Standard Deviation 8.87 |
| Placebo | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 4: Loss of Interest in Sex | -0.4 score on a scale | Standard Deviation 0.67 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 12: Total Symptom Score | -13.1 score on a scale | Standard Deviation 10.04 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 4: Loss of Interest in Sex | -0.5 score on a scale | Standard Deviation 0.88 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 8: Loss of interest in Sex | -0.7 score on a scale | Standard Deviation 1.15 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 12: Loss of Interest in Sex | -0.6 score on a scale | Standard Deviation 1.14 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 4: Psychological | -5.3 score on a scale | Standard Deviation 5.97 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 8: Psychological | -6.7 score on a scale | Standard Deviation 6.49 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 12: Psychological | -6.6 score on a scale | Standard Deviation 6.03 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 4: Physical | -1.2 score on a scale | Standard Deviation 2.71 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 8: Physical | -1.9 score on a scale | Standard Deviation 3.09 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 12: Physical | -1.9 score on a scale | Standard Deviation 3.32 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 4: Vasomotor | -3.3 score on a scale | Standard Deviation 1.83 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 8: Vasomotor | -3.6 score on a scale | Standard Deviation 1.48 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 12: Vasomotor | -3.6 score on a scale | Standard Deviation 1.37 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 4: Total Symptom Score | -9.9 score on a scale | Standard Deviation 9.24 |
| Fezolinetant | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 | Week 8: Total Symptom Score | -13.1 score on a scale | Standard Deviation 10.68 |
Comparison: Week 4: Loss of Interest in Sexp-value: 0.88195% CI: [-0.3, 0.3]ANCOVA
Comparison: Week 8: Loss of Interest in Sexp-value: 0.38395% CI: [-0.6, 0.2]ANCOVA
Comparison: Week 12: Loss of Interest in Sexp-value: 0.30195% CI: [-0.6, 0.2]ANCOVA
Comparison: Week 4: Psychologicalp-value: 0.0295% CI: [-4.5, -0.4]ANCOVA
Comparison: Week 8: Psychologicalp-value: 0.00395% CI: [-5.4, -1.2]ANCOVA
Comparison: Week 12: Psychologicalp-value: 0.00595% CI: [-5.2, -1]ANCOVA
Comparison: Week 4: Physicalp-value: 0.73295% CI: [-1.2, 0.9]ANCOVA
Comparison: Week 8: Physicalp-value: 0.28295% CI: [-1.9, 0.6]ANCOVA
Comparison: Week 12: Physicalp-value: 0.25495% CI: [-1.7, 0.5]ANCOVA
Comparison: Week 4: Vasomotorp-value: <0.00195% CI: [-2.7, -1.4]ANCOVA
Comparison: Week 8: Vasomotorp-value: <0.00195% CI: [-2.4, -1.1]ANCOVA
Comparison: Week 12: Vasomotorp-value: <0.00195% CI: [-2.6, -1.3]ANCOVA
Comparison: Week 4: Total Symptom Scorep-value: 0.01395% CI: [-8.2, -1]ANCOVA
Comparison: Week 8: Total Symptom Scorep-value: <0.00195% CI: [-10.7, -3.1]ANCOVA
Comparison: Week 12: Total Symptom Scorep-value: <0.00195% CI: [-9.9, -2.8]ANCOVA
Secondary
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
The HFRDIS was a 10-item scale which measured a woman's perceptions of the degree to which HF interfere with 9 daily life activities (work, social activities, leisure, sleep, mood, concentration, relations with others, sexuality, enjoying life); the 10th item measures interference with overall quality of life. This scale was modeled after items on the Brief Pain Inventory and Brief Fatigue Inventory both of which assessed the extent to which pain or fatigue interfere with daily life. Participants were asked to rate the extent to which HF had interfered with each item during the previous 4-week time interval using a 0 (do not interfere) to 10 (completely interfere) scale. Overall mean score was calculated as sum of items/number of available items. Higher score indicate a higher interference.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Work | -2.4 score on a scale | Standard Deviation 2.8 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Concentration | -1.9 score on a scale | Standard Deviation 3.17 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Sleep | -2.5 score on a scale | Standard Deviation 2.93 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Relations With Others | -2.1 score on a scale | Standard Deviation 2.93 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Social Activities | -1.8 score on a scale | Standard Deviation 2.51 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Relations With Others | -1.8 score on a scale | Standard Deviation 3.02 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Sleep | -3.2 score on a scale | Standard Deviation 3.29 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Relations With Others | -1.8 score on a scale | Standard Deviation 3.16 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Social Activities | -1.6 score on a scale | Standard Deviation 2.53 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Sexuality | -1.9 score on a scale | Standard Deviation 2.88 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Sleep | -3.3 score on a scale | Standard Deviation 3.01 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Sexuality | -1.8 score on a scale | Standard Deviation 3.48 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Leisure Activities | -1.6 score on a scale | Standard Deviation 2.63 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Sexuality | -1.7 score on a scale | Standard Deviation 2.84 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Mood | -2.3 score on a scale | Standard Deviation 2.49 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Enjoyment of Life | -1.6 score on a scale | Standard Deviation 2.86 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Work | -2.3 score on a scale | Standard Deviation 2.58 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Enjoyment of Life | -1.5 score on a scale | Standard Deviation 3.15 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Mood | -2.3 score on a scale | Standard Deviation 2.86 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Enjoyment of Life | -1.6 score on a scale | Standard Deviation 3.38 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Leisure Activities | -1.7 score on a scale | Standard Deviation 2.72 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Overall Quality of Life | -1.4 score on a scale | Standard Deviation 2.43 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Mood | -2.5 score on a scale | Standard Deviation 2.56 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Overall Quality of Life | -1.5 score on a scale | Standard Deviation 3.01 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Social Activities | -1.9 score on a scale | Standard Deviation 2.85 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Overall Quality of Life | -1.6 score on a scale | Standard Deviation 3.05 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Concentration | -1.6 score on a scale | Standard Deviation 2.68 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Overall Mean Score | -1.84 score on a scale | Standard Deviation 1.922 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Leisure Activities | -2.0 score on a scale | Standard Deviation 2.52 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Overall Mean Score | -1.98 score on a scale | Standard Deviation 2.439 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Concentration | -1.6 score on a scale | Standard Deviation 3.06 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Overall Mean Score | -2.05 score on a scale | Standard Deviation 2.326 |
| Placebo | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Work | -1.7 score on a scale | Standard Deviation 2.93 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Overall Mean Score | -4.17 score on a scale | Standard Deviation 2.067 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Work | -4.6 score on a scale | Standard Deviation 2.65 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Work | -5.0 score on a scale | Standard Deviation 2.38 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Work | -4.6 score on a scale | Standard Deviation 2.68 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Social Activities | -4.3 score on a scale | Standard Deviation 2.48 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Social Activities | -4.7 score on a scale | Standard Deviation 2.37 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Social Activities | -4.3 score on a scale | Standard Deviation 2.35 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Leisure Activities | -4.0 score on a scale | Standard Deviation 2.51 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Leisure Activities | -4.2 score on a scale | Standard Deviation 2.5 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Leisure Activities | -3.8 score on a scale | Standard Deviation 3.08 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Sleep | -5.2 score on a scale | Standard Deviation 2.77 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Sleep | -5.7 score on a scale | Standard Deviation 2.37 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Sleep | -5.8 score on a scale | Standard Deviation 2.43 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Mood | -4.0 score on a scale | Standard Deviation 2.85 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Mood | -4.4 score on a scale | Standard Deviation 2.84 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Mood | -4.3 score on a scale | Standard Deviation 2.64 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Concentration | -3.9 score on a scale | Standard Deviation 2.57 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Concentration | -4.1 score on a scale | Standard Deviation 2.59 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Concentration | -4.0 score on a scale | Standard Deviation 2.47 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Relations With Others | -3.3 score on a scale | Standard Deviation 2.45 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Relations With Others | -3.5 score on a scale | Standard Deviation 2.7 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Relations With Others | -3.3 score on a scale | Standard Deviation 2.67 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Sexuality | -3.0 score on a scale | Standard Deviation 3.49 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Sexuality | -3.2 score on a scale | Standard Deviation 3.76 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Sexuality | -3.4 score on a scale | Standard Deviation 3.86 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Enjoyment of Life | -3.6 score on a scale | Standard Deviation 2.65 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Enjoyment of Life | -3.9 score on a scale | Standard Deviation 2.59 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Enjoyment of Life | -3.7 score on a scale | Standard Deviation 2.42 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Overall Quality of Life | -3.8 score on a scale | Standard Deviation 2.87 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Overall Quality of Life | -4.5 score on a scale | Standard Deviation 1.92 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 12: Overall Quality of Life | -4.6 score on a scale | Standard Deviation 2.16 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 4: Overall Mean Score | -3.97 score on a scale | Standard Deviation 2.141 |
| Fezolinetant | Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 | Week 8: Overall Mean Score | -4.33 score on a scale | Standard Deviation 1.945 |
Comparison: Week 4: Workp-value: <0.00195% CI: [-3.45, -1.6]ANCOVA
Comparison: Week 8: Workp-value: <0.00195% CI: [-3.15, -1.42]ANCOVA
Comparison: Week 12: Workp-value: <0.00195% CI: [-3.03, -1.2]ANCOVA
Comparison: Week 4: Social Activitiesp-value: <0.00195% CI: [-3.19, -1.46]ANCOVA
Comparison: Week 8: Social Activtiesp-value: <0.00195% CI: [-3.21, -1.47]ANCOVA
Comparison: Week 12: Social Activtiesp-value: <0.00195% CI: [-3.09, -1.29]ANCOVA
Comparison: Week 4: Leisure Activitiesp-value: <0.00195% CI: [-2.99, -1.31]ANCOVA
Comparison: Week 8: Leisure Activtiesp-value: <0.00195% CI: [-3.19, -1.55]ANCOVA
Comparison: Week 12: Leisure Activtiesp-value: 0.00295% CI: [-2.66, -0.62]ANCOVA
Comparison: Week 4: Sleepp-value: <0.00195% CI: [-4.08, -1.78]ANCOVA
Comparison: Week 8: Sleepp-value: <0.00195% CI: [-3.86, -1.57]ANCOVA
Comparison: Week 12: Sleepp-value: <0.00195% CI: [-3.67, -1.54]ANCOVA
Comparison: Week 4: Moodp-value: <0.00195% CI: [-2.67, -0.81]ANCOVA
Comparison: Week 8: Moodp-value: <0.00195% CI: [-3.09, -1.16]ANCOVA
Comparison: Week 12: Moodp-value: <0.00195% CI: [-2.69, -0.88]ANCOVA
Comparison: Week 4: Concentrationp-value: <0.00195% CI: [-2.86, -0.97]ANCOVA
Comparison: Week 8: Concentrationp-value: <0.00194% CI: [-3.21, -1.25]ANCOVA
Comparison: Week 12: Concentrationp-value: <0.00195% CI: [-2.91, -0.88]ANCOVA
Comparison: Week 4: Relations With Othersp-value: 0.00395% CI: [-2.2, -0.46]ANCOVA
Comparison: Week 8: Relations With othersp-value: <0.00195% CI: [-2.8, -0.9]ANCOVA
Comparison: Week 12: Relations With Othersp-value: <0.00195% CI: [-2.66, -0.77]ANCOVA
Comparison: Week 4: Sexualityp-value: 0.08195% CI: [-2.25, 0.13]ANCOVA
Comparison: Week 8: Sexualityp-value: 0.0595% CI: [-2.8, 0]ANCOVA
Comparison: Week 12: Sexualityp-value: 0.02695% CI: [-2.84, -0.19]ANCOVA
Comparison: Week 4: Enjoyment of Lifep-value: <0.00195% CI: [-2.51, -0.79]ANCOVA
Comparison: Week 8: Enjoyment of Lifep-value: <0.00195% CI: [-2.97, -1.18]ANCOVA
Comparison: Week 12: Enjoyment of Lifep-value: <0.00195% CI: [-2.88, -0.78]ANCOVA
Comparison: Week4: Overall Quality of Lifep-value: <0.00195% CI: [-2.86, -0.97]ANCOVA
Comparison: Week 8: Overall Quality of Lifep-value: <0.00195% CI: [-3.41, -1.61]ANCOVA
Comparison: Week 12: Overall Quality of Lifep-value: <0.00195% CI: [-3.31, -1.41]ANCOVA
Comparison: Week 4: Overall Mean Scorep-value: <0.00195% CI: [-2.73, -1.23]ANCOVA
Comparison: Week 8: Overall Mean Scorep-value: <0.00195% CI: [-3.02, -1.4]ANCOVA
Comparison: Week 12: Overall Mean Scorep-value: <0.00195% CI: [-2.83, -1.13]ANCOVA
Secondary
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
The LSEQ was a 10-item self-rated questionnaire which assessed participants aspects of sleep and early morning behavior. The questions were grouped into 4 chronological areas: the ease of getting to sleep, the perceived quality of sleep, the ease of awaking from sleep, and the integrity of early morning behavior following wakefulness. The LSEQ was a visual analogue scale which requires respondents to place marks on a group of 10 cm lines. representing the changes they have experienced in a variety of symptoms since the beginning of treatment. Lines extends between extremes like more difficult than usual and easier than usual. Responses are measured using a 100-mm scale and are averaged to provide a score for each domain.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 4: Getting to Sleep | 1.017 millimeter (mm) | Standard Deviation 1.9195 |
| Placebo | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 8: Getting to Sleep | 1.145 millimeter (mm) | Standard Deviation 1.7931 |
| Placebo | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 12: Getting to Sleep | 1.282 millimeter (mm) | Standard Deviation 1.7761 |
| Placebo | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 4: Quality of Sleep | 2.145 millimeter (mm) | Standard Deviation 2.6443 |
| Placebo | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 8: Quality of Sleep | 2.378 millimeter (mm) | Standard Deviation 2.816 |
| Placebo | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 12: Quality of Sleep | 1.904 millimeter (mm) | Standard Deviation 2.7872 |
| Placebo | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 4: Awake Following Sleep | 0.642 millimeter (mm) | Standard Deviation 2.0739 |
| Placebo | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 8: Awake Following Sleep | 0.653 millimeter (mm) | Standard Deviation 2.5019 |
| Placebo | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 12: Awake Following Sleep | 1.024 millimeter (mm) | Standard Deviation 2.6114 |
| Placebo | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 4: Behavior Following Wakening | 1.173 millimeter (mm) | Standard Deviation 2.1743 |
| Placebo | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 8: Behavior Following Wakening | 0.750 millimeter (mm) | Standard Deviation 2.6371 |
| Placebo | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 12: Behavior Following Wakening | 1.203 millimeter (mm) | Standard Deviation 2.5185 |
| Fezolinetant | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 8: Behavior Following Wakening | 2.539 millimeter (mm) | Standard Deviation 2.7742 |
| Fezolinetant | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 4: Getting to Sleep | 2.283 millimeter (mm) | Standard Deviation 2.7364 |
| Fezolinetant | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 4: Awake Following Sleep | 2.180 millimeter (mm) | Standard Deviation 3.0579 |
| Fezolinetant | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 8: Getting to Sleep | 2.248 millimeter (mm) | Standard Deviation 2.5233 |
| Fezolinetant | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 4: Behavior Following Wakening | 2.513 millimeter (mm) | Standard Deviation 2.7919 |
| Fezolinetant | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 12: Getting to Sleep | 2.094 millimeter (mm) | Standard Deviation 2.4419 |
| Fezolinetant | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 8: Awake Following Sleep | 2.920 millimeter (mm) | Standard Deviation 3.0219 |
| Fezolinetant | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 4: Quality of Sleep | 4.437 millimeter (mm) | Standard Deviation 4.0768 |
| Fezolinetant | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 12: Behavior Following Wakening | 2.233 millimeter (mm) | Standard Deviation 2.819 |
| Fezolinetant | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 8: Quality of Sleep | 4.703 millimeter (mm) | Standard Deviation 3.1971 |
| Fezolinetant | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 12: Awake Following Sleep | 2.887 millimeter (mm) | Standard Deviation 3.1333 |
| Fezolinetant | Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 | Week 12: Quality of Sleep | 4.385 millimeter (mm) | Standard Deviation 3.4477 |
Comparison: Week 8: Awake Following Sleepp-value: 0.00195% CI: [0.579, 2.335]ANCOVA
Comparison: Week 12: Awake Following Sleepp-value: 0.03195% CI: [0.107, 2.12]ANCOVA
Comparison: Week 4: Behaviour Following Wakeningp-value: 0.00895% CI: [0.317, 2.088]ANCOVA
Comparison: Week 4: Getting to Sleepp-value: <0.00195% CI: [0.651, 2.1]ANCOVA
Comparison: Week 8: Getting to Sleepp-value: <0.00195% CI: [0.505, 1.827]ANCOVA
Comparison: Week 12: Getting to Sleepp-value: 0.01495% CI: [0.19, 1.599]ANCOVA
Comparison: Week 4: Quality of Sleepp-value: <0.00195% CI: [1.308, 3.539]ANCOVA
Comparison: Week 8: Quality of Sleepp-value: <0.00195% CI: [1.31, 3.251]ANCOVA
Comparison: Week 12: Quality of Sleepp-value: <0.00195% CI: [1.334, 3.532]ANCOVA
Comparison: Week 4: Awake Following Sleepp-value: 0.05995% CI: [-0.034, 1.789]ANCOVA
Comparison: Week 8: Behaviour Following Wakeningp-value: 0.00195% CI: [0.639, 2.556]ANCOVA
Comparison: Week 12: Behaviour Following Sleepp-value: 0.08495% CI: [-0.116, 1.8]ANCOVA
Secondary
Change From Baseline in Plasma Concentration of Bone Alkaline Phosphatase (BALP) at Week 12
Change from baseline in plasma concentration of BALP was reported.
Time frame: Baseline and week 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Plasma Concentration of Bone Alkaline Phosphatase (BALP) at Week 12 | 2.9 microgram per milliliter (ug/mL) | Standard Deviation 5.43 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Bone Alkaline Phosphatase (BALP) at Week 12 | 1.7 microgram per milliliter (ug/mL) | Standard Deviation 3.19 |
Secondary
Change From Baseline in Plasma Concentration of Carboxy-terminal Telopeptide of Type I Collagen (CTX) at Week 12
Change from baseline in plasma concentration of CTX was reported.
Time frame: Baseline and week 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Plasma Concentration of Carboxy-terminal Telopeptide of Type I Collagen (CTX) at Week 12 | -0.021 ug/mL | Standard Deviation 0.1278 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Carboxy-terminal Telopeptide of Type I Collagen (CTX) at Week 12 | 0.001 ug/mL | Standard Deviation 0.1356 |
Secondary
Change From Baseline in Plasma Concentration of C-peptide
Change From baseline in plasma concentration of C-peptide was reported.
Time frame: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15)
Population: Safety population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Plasma Concentration of C-peptide | Week 4: Pre-dose | -0.0465 ng/mL | Standard Deviation 0.3978 |
| Placebo | Change From Baseline in Plasma Concentration of C-peptide | Week 12: 3h | 2.1325 ng/mL | Standard Deviation 1.9976 |
| Placebo | Change From Baseline in Plasma Concentration of C-peptide | Week 12: Pre-dose | -0.0750 ng/mL | Standard Deviation 0.5212 |
| Placebo | Change From Baseline in Plasma Concentration of C-peptide | Week 15 | -0.0047 ng/mL | Standard Deviation 0.6102 |
| Placebo | Change From Baseline in Plasma Concentration of C-peptide | Week 8: Pre-dose | -0.0300 ng/mL | Standard Deviation 0.5273 |
| Fezolinetant | Change From Baseline in Plasma Concentration of C-peptide | Week 15 | -0.0095 ng/mL | Standard Deviation 0.4023 |
| Fezolinetant | Change From Baseline in Plasma Concentration of C-peptide | Week 8: Pre-dose | -0.1175 ng/mL | Standard Deviation 0.475 |
| Fezolinetant | Change From Baseline in Plasma Concentration of C-peptide | Week 4: Pre-dose | -0.1463 ng/mL | Standard Deviation 0.5134 |
| Fezolinetant | Change From Baseline in Plasma Concentration of C-peptide | Week 12: Pre-dose | -0.0425 ng/mL | Standard Deviation 0.7154 |
| Fezolinetant | Change From Baseline in Plasma Concentration of C-peptide | Week 12: 3h | 2.2875 ng/mL | Standard Deviation 2.1811 |
Secondary
Change From Baseline in Plasma Concentration of Estradiol (E2)
Change From baseline in plasma concentration of E2 was reported.
Time frame: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15)
Population: Safety population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Plasma Concentration of Estradiol (E2) | Week 8: Pre-dose | 26.0 Picomoles per liter (pmol/L) | Standard Deviation 157.18 |
| Placebo | Change From Baseline in Plasma Concentration of Estradiol (E2) | Week 12: 3h | 26.0 Picomoles per liter (pmol/L) | Standard Deviation 100.33 |
| Placebo | Change From Baseline in Plasma Concentration of Estradiol (E2) | Week 12: Pre-dose | 32.3 Picomoles per liter (pmol/L) | Standard Deviation 101.87 |
| Placebo | Change From Baseline in Plasma Concentration of Estradiol (E2) | Week 15 | 37.0 Picomoles per liter (pmol/L) | Standard Deviation 167.37 |
| Placebo | Change From Baseline in Plasma Concentration of Estradiol (E2) | Week 4: Pre-dose | 18.4 Picomoles per liter (pmol/L) | Standard Deviation 140.36 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Estradiol (E2) | Week 15 | 27.9 Picomoles per liter (pmol/L) | Standard Deviation 188.18 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Estradiol (E2) | Week 4: Pre-dose | -7.3 Picomoles per liter (pmol/L) | Standard Deviation 75.13 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Estradiol (E2) | Week 8: Pre-dose | 1.0 Picomoles per liter (pmol/L) | Standard Deviation 71.78 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Estradiol (E2) | Week 12: Pre-dose | 25.5 Picomoles per liter (pmol/L) | Standard Deviation 108.27 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Estradiol (E2) | Week 12: 3h | 11.5 Picomoles per liter (pmol/L) | Standard Deviation 77.68 |
Secondary
Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH)
Change From baseline in plasma concentration of FSH was reported.
Time frame: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15)
Population: Safety population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH) | Week 8: Pre-dose | -6.60 IU/L | Standard Deviation 20.086 |
| Placebo | Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH) | Week 12: 3h | -8.47 IU/L | Standard Deviation 19.159 |
| Placebo | Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH) | Week 12: Pre-dose | -7.05 IU/L | Standard Deviation 19.978 |
| Placebo | Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH) | Week 15 | -6.50 IU/L | Standard Deviation 21.011 |
| Placebo | Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH) | Week 4: Pre-dose | -5.80 IU/L | Standard Deviation 19.43 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH) | Week 15 | -6.97 IU/L | Standard Deviation 22.273 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH) | Week 4: Pre-dose | -3.44 IU/L | Standard Deviation 18.026 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH) | Week 8: Pre-dose | -10.36 IU/L | Standard Deviation 23.943 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH) | Week 12: Pre-dose | -10.51 IU/L | Standard Deviation 24.521 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH) | Week 12: 3h | -19.48 IU/L | Standard Deviation 22.734 |
Secondary
Change From Baseline in Plasma Concentration of Glycated Hemoglobin (HBA1c)
Change From baseline in plasma concentration of HBA1C was reported.
Time frame: Baseline and week 12
Population: Safety population with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Plasma Concentration of Glycated Hemoglobin (HBA1c) | -0.00050000 Percentage of HBA1c | Standard Deviation 0.003162278 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Glycated Hemoglobin (HBA1c) | -0.002307692 Percentage of HBA1c | Standard Deviation 0.0048458 |
Secondary
Change From Baseline in Plasma Concentration of Insulin
Change From baseline in plasma concentration of insulin was reported.
Time frame: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15)
Population: Safety population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Plasma Concentration of Insulin | Week 8: Pre-dose | 0.3525 micro units per milliliter (μU/mL) | Standard Deviation 4.0903 |
| Placebo | Change From Baseline in Plasma Concentration of Insulin | Week 12: 3h | 16.3225 micro units per milliliter (μU/mL) | Standard Deviation 19.021 |
| Placebo | Change From Baseline in Plasma Concentration of Insulin | Week 12: Pre-dose | -0.0825 micro units per milliliter (μU/mL) | Standard Deviation 3.1593 |
| Placebo | Change From Baseline in Plasma Concentration of Insulin | Week 15 | 0.3256 micro units per milliliter (μU/mL) | Standard Deviation 4.1132 |
| Placebo | Change From Baseline in Plasma Concentration of Insulin | Week 4: Pre-dose | -0.2767 micro units per milliliter (μU/mL) | Standard Deviation 3.0971 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Insulin | Week 15 | -0.1595 micro units per milliliter (μU/mL) | Standard Deviation 3.1071 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Insulin | Week 4: Pre-dose | -0.7512 micro units per milliliter (μU/mL) | Standard Deviation 3.8798 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Insulin | Week 8: Pre-dose | -0.5325 micro units per milliliter (μU/mL) | Standard Deviation 3.6121 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Insulin | Week 12: Pre-dose | 0.1300 micro units per milliliter (μU/mL) | Standard Deviation 4.7942 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Insulin | Week 12: 3h | 14.4950 micro units per milliliter (μU/mL) | Standard Deviation 19.2787 |
Secondary
Change From Baseline in Plasma Concentration of Leptin
Change From baseline in plasma concentration of leptin was reported.
Time frame: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15)
Population: Safety population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Plasma Concentration of Leptin | Week 8: Pre-dose | 1.6225 nanogram per liter (ng/mL) | Standard Deviation 7.5029 |
| Placebo | Change From Baseline in Plasma Concentration of Leptin | Week 12: 3h | -2.0755 nanogram per liter (ng/mL) | Standard Deviation 5.3193 |
| Placebo | Change From Baseline in Plasma Concentration of Leptin | Week 12: Pre-dose | 0.9668 nanogram per liter (ng/mL) | Standard Deviation 5.4301 |
| Placebo | Change From Baseline in Plasma Concentration of Leptin | Week 15 | -0.9914 nanogram per liter (ng/mL) | Standard Deviation 14.666 |
| Placebo | Change From Baseline in Plasma Concentration of Leptin | Week 4: Pre-dose | 1.2436 nanogram per liter (ng/mL) | Standard Deviation 5.6269 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Leptin | Week 15 | -0.6031 nanogram per liter (ng/mL) | Standard Deviation 8.2519 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Leptin | Week 4: Pre-dose | -2.2185 nanogram per liter (ng/mL) | Standard Deviation 6.9522 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Leptin | Week 8: Pre-dose | -1.7090 nanogram per liter (ng/mL) | Standard Deviation 6.9716 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Leptin | Week 12: Pre-dose | -0.4183 nanogram per liter (ng/mL) | Standard Deviation 11.0737 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Leptin | Week 12: 3h | -4.2085 nanogram per liter (ng/mL) | Standard Deviation 8.5335 |
Secondary
Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH)
Change From baseline in plasma concentration of LH was reported.
Time frame: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12: 3h, follow-up (week 15)
Population: Safety population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH) | Week 15 | -6.16 international unit per liter (IU/L) | Standard Deviation 14.197 |
| Placebo | Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH) | Week 4: Pre-dose | -2.34 international unit per liter (IU/L) | Standard Deviation 9.35 |
| Placebo | Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH) | Week 8: Pre-dose | -3.86 international unit per liter (IU/L) | Standard Deviation 9.838 |
| Placebo | Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH) | Week 12: Pre-dose | -4.61 international unit per liter (IU/L) | Standard Deviation 13.304 |
| Placebo | Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH) | Week 12: 3 hours (h) | -7.16 international unit per liter (IU/L) | Standard Deviation 13.009 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH) | Week 12: 3 hours (h) | -21.78 international unit per liter (IU/L) | Standard Deviation 11.923 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH) | Week 12: Pre-dose | -9.72 international unit per liter (IU/L) | Standard Deviation 12.834 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH) | Week 4: Pre-dose | -8.84 international unit per liter (IU/L) | Standard Deviation 10.865 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH) | Week 15 | -3.33 international unit per liter (IU/L) | Standard Deviation 11.742 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH) | Week 8: Pre-dose | -9.46 international unit per liter (IU/L) | Standard Deviation 13.647 |
Secondary
Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG)
Change From baseline in plasma concentration of SHBG was reported.
Time frame: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15)
Population: Safety population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG) | Week 8: Pre-dose | 5.10 Nanomoles per liter (nmol/L) | Standard Deviation 20.713 |
| Placebo | Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG) | Week 12: 3h | 1.56 Nanomoles per liter (nmol/L) | Standard Deviation 18.658 |
| Placebo | Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG) | Week 12: Pre-dose | 1.75 Nanomoles per liter (nmol/L) | Standard Deviation 18.09 |
| Placebo | Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG) | Week 15 | 1.92 Nanomoles per liter (nmol/L) | Standard Deviation 16.341 |
| Placebo | Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG) | Week 4: Pre-dose | 0.61 Nanomoles per liter (nmol/L) | Standard Deviation 16.26 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG) | Week 15 | -0.86 Nanomoles per liter (nmol/L) | Standard Deviation 13.54 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG) | Week 4: Pre-dose | -0.47 Nanomoles per liter (nmol/L) | Standard Deviation 11.986 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG) | Week 8: Pre-dose | -1.37 Nanomoles per liter (nmol/L) | Standard Deviation 12.186 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG) | Week 12: Pre-dose | 0.36 Nanomoles per liter (nmol/L) | Standard Deviation 15.165 |
| Fezolinetant | Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG) | Week 12: 3h | -1.49 Nanomoles per liter (nmol/L) | Standard Deviation 16.406 |
Secondary
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
The SDS was a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in a participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his/her 1- work/school, 2- social life, and 3- family life are impaired by his/her symptoms on a 10-point visual analog scale. The 3 items could be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).Higher scores indicate significant functional impairment.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 4: Work/School | -1.3 score on a scale | Standard Deviation 2.43 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 8: Work/School | -1.7 score on a scale | Standard Deviation 2.56 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 12: Work/School | -1.8 score on a scale | Standard Deviation 2.76 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 4: Social Life | -1.2 score on a scale | Standard Deviation 2.35 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 8: Social Life | -1.3 score on a scale | Standard Deviation 2.57 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 12: Social Life | -1.5 score on a scale | Standard Deviation 2.55 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 4: Family Life/Home Responsibilities | -1.5 score on a scale | Standard Deviation 2.7 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 8: Family Life/Home Responsibilities | -1.7 score on a scale | Standard Deviation 2.64 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 12: Family Life/Home Responsibilities | -1.7 score on a scale | Standard Deviation 2.38 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 4: Global Functional Impairment | -3.7 score on a scale | Standard Deviation 5.5 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 8: Global Functional Impairment | -4.5 score on a scale | Standard Deviation 6.87 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 12: Global Functional Impairment | -4.8 score on a scale | Standard Deviation 6.49 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 8: Global Functional Impairment | -12.3 score on a scale | Standard Deviation 6.42 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 4: Work/School | -3.6 score on a scale | Standard Deviation 2.78 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 4: Family Life/Home Responsibilities | -3.3 score on a scale | Standard Deviation 2.97 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 8: Work/School | -4.4 score on a scale | Standard Deviation 2.43 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 4: Global Functional Impairment | -9.6 score on a scale | Standard Deviation 6.99 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 12: Work/School | -4.3 score on a scale | Standard Deviation 2.47 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 8: Family Life/Home Responsibilities | -4.0 score on a scale | Standard Deviation 2.83 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 4: Social Life | -3.3 score on a scale | Standard Deviation 2.6 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 12: Global Functional Impairment | -11.8 score on a scale | Standard Deviation 6.35 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 8: Social Life | -3.8 score on a scale | Standard Deviation 2.79 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 12: Family Life/Home Responsibilities | -3.7 score on a scale | Standard Deviation 2.65 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 | Week 12: Social Life | -3.6 score on a scale | Standard Deviation 2.51 |
Comparison: Week 4: Work/Schoolp-value: <0.00195% CI: [-2.7, -0.8]ANCOVA
Comparison: Week 8: Work/Schoolp-value: <0.00195% CI: [-2.8, -1.3]ANCOVA
Comparison: Week 12: Work/Schoolp-value: <0.00195% CI: [-2.5, -0.8]ANCOVA
Comparison: Week 4: Social Lifep-value: <0.00195% CI: [-2.2, -0.6]ANCOVA
Comparison: Week 8: Social Lifep-value: <0.00195% CI: [-2.7, -1.1]ANCOVA
Comparison: Week 12: Social Lifep-value: <0.00195% CI: [-2.4, -0.7]ANCOVA
Comparison: Week 4: Family Life/Home Responsibilitiesp-value: 0.00595% CI: [-2.2, -0.4]ANCOVA
Comparison: Week 8: Family Life/Home Responsibilitiesp-value: <0.00195% CI: [-2.5, -0.9]ANCOVA
Comparison: Week 12: Family Life/Home Responsibilitiesp-value: <0.00195% CI: [-2.4, -0.7]ANCOVA
Comparison: Week 4: Global Functional Impairmentp-value: <0.00195% CI: [-6.9, -2]ANCOVA
Comparison: Week 8: Global Functional Impairmentp-value: <0.00195% CI: [-8, -3.6]ANCOVA
Comparison: Week 12: Global Functional Impairmentp-value: <0.00195% CI: [-7.8, -2.8]ANCOVA
Secondary
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive)
The SDS was a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in a participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his/her 1- work/school, 2- social life, and 3- family life are impaired by his/her symptoms. In addition to the 3 items, the participants were asked two questions Days Lost: On how many days in the last week did your symptoms cause you to miss school or work or leave you unable to carry out your normal daily responsibilities? Day Unproductive: On how many days in the last week did you feel so impaired by your symptoms, that even though you went to school or work, your productivity was reduced?
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Week 4: Days Lost | -0.2 days | Standard Deviation 1.27 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Week 8: Days Lost | -0.3 days | Standard Deviation 0.81 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Week 12: Days Lost | -0.2 days | Standard Deviation 1.18 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Week 4: Days Unproductive | -0.8 days | Standard Deviation 2.83 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Week 8: Days Unproductive | -1.2 days | Standard Deviation 3.1 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Week 12: Days Unproductive | -1.4 days | Standard Deviation 2.82 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Week 8: Days Unproductive | -2.0 days | Standard Deviation 2.55 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Week 4: Days Lost | 0.0 days | Standard Deviation 0.73 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Week 4: Days Unproductive | -1.7 days | Standard Deviation 2.67 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Week 8: Days Lost | 0.0 days | Standard Deviation 0 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Week 12: Days Unproductive | -2.2 days | Standard Deviation 2.59 |
| Fezolinetant | Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) | Week 12: Days Lost | 0.0 days | Standard Deviation 0 |
Comparison: Week 4: Days Lostp-value: 0.93695% CI: [-0.5, 0.6]ANCOVA
Comparison: Week 8: Days Lostp-value: 0.88495% CI: [-0.1, 0.1]ANCOVA
Comparison: Week 12: Days Lostp-value: 0.12495% CI: [-0.4, 0.1]ANCOVA
Comparison: Week 4: Days Unproductivep-value: 0.05295% CI: [-1.8, 0]ANCOVA
Comparison: Week 8: Days Unproductivep-value: 0.0695% CI: [-1.7, 0]ANCOVA
Comparison: Week 12: Days Unproductivep-value: 0.04995% CI: [-1.7, 0]ANCOVA
Secondary
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)
The HF Severity Score by method 1 takes into account the number and severity of moderate and severe HF occurred during a given time period and was calculated as follows HF Severity score = \[(number of moderate HF/day × 2) + (number of severe HF/day × 3)\]/(number of moderate HF + number of severe HF) The severity of HFs was clinically defined as follows: * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1) | Week 4 | -0.294 score on a scale |
| Placebo | Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1) | Week 8 | -0.608 score on a scale |
| Placebo | Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1) | Week 12 | -0.534 score on a scale |
| Fezolinetant | Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1) | Week 4 | -1.428 score on a scale |
| Fezolinetant | Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1) | Week 8 | -1.557 score on a scale |
| Fezolinetant | Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1) | Week 12 | -1.656 score on a scale |
Comparison: Week 4p-value: <0.00195% CI: [-1.466, -0.802]ANCOVA
Comparison: Week 8p-value: <0.00195% CI: [-1.362, -0.535]ANCOVA
Comparison: Week 12p-value: <0.00195% CI: [-1.504, -0.741]ANCOVA
Secondary
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2)
The HF Severity Score by method 2 takes into account moderate and severe HF during a given time period and was calculated as follows HF Severity score = \[(number of moderate HF/day × 2) + (number of severe HF/day × 3)\] The severity of HFs was clinically defined as follows: * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2) | Week 4 | -9.55 score on a scale |
| Placebo | Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2) | Week 8 | -11.91 score on a scale |
| Placebo | Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2) | Week 12 | -12.14 score on a scale |
| Fezolinetant | Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2) | Week 4 | -25.26 score on a scale |
| Fezolinetant | Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2) | Week 8 | -25.71 score on a scale |
| Fezolinetant | Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2) | Week 12 | -26.61 score on a scale |
Comparison: Week 4p-value: <0.00195% CI: [-17.02, -9.54]ANCOVA
Comparison: Week 8p-value: <0.00195% CI: [-16.3, -7.27]ANCOVA
Comparison: Week 12p-value: <0.00195% CI: [-17, -7.83]ANCOVA
Secondary
Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12
The weekly HF frequency was calculated as number of mild, moderate and severe hot flashes over the week. * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of hot flashes is worse.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12 | Week 4 | -26.4 HF's per day |
| Placebo | Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12 | Week 8 | -32.9 HF's per day |
| Placebo | Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12 | Week 12 | -35.6 HF's per day |
| Fezolinetant | Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12 | Week 4 | -72.3 HF's per day |
| Fezolinetant | Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12 | Week 8 | -73.3 HF's per day |
| Fezolinetant | Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12 | Week 12 | -75.3 HF's per day |
Comparison: Week 4p-value: <0.00195% CI: [-50.5, -29.1]ANCOVA
Comparison: Week 8p-value: <0.00195% CI: [-47.9, -23]ANCOVA
Comparison: Week 12p-value: <0.00195% CI: [-47.9, -22.1]ANCOVA
Secondary
Number of Participants With Adverse Events (AE's)
An AE is any untoward medical occurrence in a participant administered a study drug, & which does not necessarily have to have a causal relationship with treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with use of a medicinal product (mp) whether or not considered related to the mp. An AE is considered serious if 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, results in congenital anomaly or birth defect, requires inparticipant hospitalization or leads to prolongation of hospitalization, hospitalization for treatment/observation/examination caused by AE is to be considered as serious, discontinuation due to increases in liver enzymes, other medically important events. TEAE was defined as an AE observed from first dose date up to end of study.
Time frame: From first dose of study drug until end of the study (Up to week 15)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AE's) | At least one TEAE | 35 participants |
| Placebo | Number of Participants With Adverse Events (AE's) | At least one serious TEAE | 1 participants |
| Placebo | Number of Participants With Adverse Events (AE's) | At least one TEAE leading to death | 0 participants |
| Placebo | Number of Participants With Adverse Events (AE's) | At least one severe TEAE | 0 participants |
| Placebo | Number of Participants With Adverse Events (AE's) | At least one TEAE for which the study treatment was permanently stopped | 0 participants |
| Placebo | Number of Participants With Adverse Events (AE's) | At least one TEAE that was considered treatment related | 11 participants |
| Fezolinetant | Number of Participants With Adverse Events (AE's) | At least one TEAE for which the study treatment was permanently stopped | 2 participants |
| Fezolinetant | Number of Participants With Adverse Events (AE's) | At least one TEAE | 29 participants |
| Fezolinetant | Number of Participants With Adverse Events (AE's) | At least one severe TEAE | 0 participants |
| Fezolinetant | Number of Participants With Adverse Events (AE's) | At least one serious TEAE | 0 participants |
| Fezolinetant | Number of Participants With Adverse Events (AE's) | At least one TEAE that was considered treatment related | 13 participants |
| Fezolinetant | Number of Participants With Adverse Events (AE's) | At least one TEAE leading to death | 0 participants |
Secondary
Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12
The weekly HF frequency of moderate and severe HF was calculated as number of moderate and severe HF over the week. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of HF indicates worse symptoms.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 4 | 45.5 percentage of participants |
| Placebo | Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 8 | 53.7 percentage of participants |
| Placebo | Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 12 | 55.0 percentage of participants |
| Fezolinetant | Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 4 | 95.1 percentage of participants |
| Fezolinetant | Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 8 | 97.5 percentage of participants |
| Fezolinetant | Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 12 | 97.5 percentage of participants |
Comparison: Week 4p-value: <0.00195% CI: [33.54, 65.79]Likelihood-Ratio Chi-Square Test
Comparison: Week 8p-value: <0.00195% CI: [27.83, 59.85]Likelihood-Ratio Chi-Square Test
Comparison: Week 12p-value: <0.00195% CI: [26.34, 58.66]Likelihood-Ratio Chi-Square Test
Secondary
Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12
The weekly HF frequency of moderate and severe HF was calculated as number of moderate and severe HF over the week. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of HF indicates worse symptoms.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 4 | 25.0 percentage of participants |
| Placebo | Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 8 | 46.3 percentage of participants |
| Placebo | Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 12 | 40.0 percentage of participants |
| Fezolinetant | Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 4 | 87.8 percentage of participants |
| Fezolinetant | Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 8 | 92.5 percentage of participants |
| Fezolinetant | Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 12 | 97.5 percentage of participants |
Comparison: Week 4p-value: <0.00195% CI: [46.56, 79.05]Likelihood-Ratio Chi-Square Test
Comparison: Week 8p-value: <0.00195% CI: [28.85, 63.47]Likelihood-Ratio Chi-Square Test
Comparison: Week 12p-value: <0.00195% CI: [41.57, 73.43]Likelihood-Ratio Chi-Square Test
Secondary
Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12
The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HFs is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 4 | 22.7 percentage of participants |
| Placebo | Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 8 | 39.0 percentage of participants |
| Placebo | Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 12 | 42.5 percentage of participants |
| Fezolinetant | Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 4 | 87.8 percentage of participants |
| Fezolinetant | Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 8 | 87.5 percentage of participants |
| Fezolinetant | Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 12 | 95.0 percentage of participants |
Comparison: Week 4p-value: <0.00195% CI: [49.15, 81]Likelihood-Ratio Chi-Square Test
Comparison: Week 8p-value: <0.00195% CI: [30.37, 66.59]Likelihood-Ratio Chi-Square Test
Comparison: Week 12p-value: <0.00195% CI: [35.76, 69.24]Likelihood-Ratio Chi-Square Test
Secondary
Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12
The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HFs is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 4 | 9.1 percentage of participants |
| Placebo | Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 8 | 26.8 percentage of participants |
| Placebo | Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 12 | 30.0 percentage of participants |
| Fezolinetant | Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 4 | 78.0 percentage of participants |
| Fezolinetant | Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 8 | 77.5 percentage of participants |
| Fezolinetant | Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 12 | 87.5 percentage of participants |
Comparison: Week 4p-value: <0.00195% CI: [53.7, 84.21]Likelihood-Ratio Chi-Square Test
Comparison: Week 8p-value: <0.00195% CI: [31.93, 69.42]Likelihood-Ratio Chi-Square Test
Comparison: Week 12p-value: <0.00195% CI: [39.99, 75.01]Likelihood-Ratio Chi-Square Test
Secondary
Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12
The weekly HF frequency of moderate and severe HF was calculated as number of moderate and severe HF over the week. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of HF indicates worse symptoms.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 4 | 6.8 percentage of participants |
| Placebo | Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 8 | 24.4 percentage of participants |
| Placebo | Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 12 | 20.0 percentage of participants |
| Fezolinetant | Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 4 | 68.3 percentage of participants |
| Fezolinetant | Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 8 | 67.5 percentage of participants |
| Fezolinetant | Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 | Week 12 | 72.5 percentage of participants |
Comparison: Week 4p-value: <0.00195% CI: [45.4, 77.55]Likelihood-Ratio Chi-Square Test
Comparison: Week 8p-value: <0.00195% CI: [23.53, 62.69]Likelihood-Ratio Chi-Square Test
Comparison: Week 12p-value: <0.00195% CI: [33.92, 71.08]Likelihood-Ratio Chi-Square Test
Secondary
Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12
The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HF is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. * Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Time frame: Baseline and weeks 4, 8 and 12
Population: ITT population with available data at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 4 | 6.8 percentage of participants |
| Placebo | Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 8 | 12.2 percentage of participants |
| Placebo | Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 12 | 15.0 percentage of participants |
| Fezolinetant | Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 4 | 61.0 percentage of participants |
| Fezolinetant | Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 8 | 60.0 percentage of participants |
| Fezolinetant | Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 | Week 12 | 62.5 percentage of participants |
Comparison: Week 4p-value: <0.00195% CI: [37.47, 70.84]Likelihood-Ratio Chi-Square Test
Comparison: Week 8p-value: <0.00195% CI: [29.62, 65.99]Likelihood-Ratio Chi-Square Test
Comparison: Week 12p-value: <0.00195% CI: [28.86, 66.14]Likelihood-Ratio Chi-Square Test