Postmenopausal Symptoms
Conditions
Keywords
Hot Flashes, Vasomotor Symptoms, Menopause
Brief summary
The purpose of this study is to assess the efficacy and safety of repeated administration of G-CSF for the treatment of hot flashes and vasomotor symptoms in women with naturally-occurring or surgically induced menopause. G-CSF will be administered three times at 28 day intervals to postmenopausal women, ages 40 to 65, suffering at least 49 moderate to severe hot flashes per week.
Detailed description
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled study. Eligible subjects will be stratified by natural or surgical menopause and randomized (1:1) to receive 3 single injections, 28-days apart, of either G-CSF or placebo. This study will consist of a 14-21 day screening period. Subjects enrolled will be given three single 1.0 mL subcutaneous (SC) injections (repeated 28-days apart), in the outer area of either upper arm, of either G-CSF or placebo (sterile physiological saline) at Baseline, Day 28 and Day 56. Subjects will be followed for 12 weeks and will complete hot flash diary entries every day for the duration of treatment. Safety will be assessed by adverse events, clinical laboratory tests (clinical chemistry and complete blood count with differential) and vital signs. A follow-up phone call will occur 60 days after the last dose of study drug. Eligibility will be assessed via physical examination, clinical laboratory testing, vital signs. Subjects will receive a diary in which to record daily hot flashes symptoms during the duration of the screening period. Subjects must have at least 14 days of hot flash recordings to participate in the study. The diary will be reviewed by study site staff on Baseline (Day 0) to confirm study eligibility. During the treatment period, subjects will return to the study site at Days 1, 21, 28, 29, 49, 56, 57, and 84 for assessments. The follow-up phone call will occur approximately 60 days following the last dose of study drug.
Interventions
BIOLOGICALG-CSF
G-CSF injected subcutaneously 3 times (Days 0, 28, 56)
OTHERPlacebo/Saline
Placebo/saline injected subcutaneously 3 times (Days 0, 28, 56)
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
MenoGeniX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female, aged 49 to 65 for natural postmenopausal or aged 40 to 65 for surgical postmenopausal * Body Mass Index (BMI) 18 to 35 * At least 7 moderate to severe hot flashes per day on average (or at least 49 moderate to severe hot flashes per week) * Naturally postmenopausal or surgically postmenopausal women: * Naturally postmenopausal is defined as having no menstrual periods for at least 12 months prior to study entry; with a biochemical criteria of menopause (FSH \>40 IU/L) * Surgically postmenopausal is defined as at least 3 months after documented bilateral salpingo oophorectomy * Normal pelvic exam and pap smear within 2 years * Signed informed consent
Exclusion criteria
* Radiation or chemotherapy-induced (including gonadotropin-releasing hormone (GnRH) agonist) menopause * Prior chemotherapy or radiation therapy for cancer * Prior diagnosis of hematologic malignancy * Type 1 diabetics or Type 2 diabetics with HbA1c \> 7.0% * Use of hormone replacement therapy or oral contraceptives within the past three months * Use of alternative or complementary medicines or herbs for menopausal symptoms within 30 days (refer to Appendix 2) * Use of any selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) within 30 days * Use of selective estrogen receptor modulators within 30 days * Use of gabapentin within 30 days * Use of clonidine within 30 days * Use of megestrol acetate (Megace) within 30 days * Use of, prescription corticosteroids within 30 days (nasal or other inhaled corticosteroids and over-the-counter (OTC) hydrocortisone ointment or cream excepted) * Current use of lithium therapy (related to possible risk of G-CSF) * History (in the past year) or presence of drug or alcohol use which, in the opinion of the Investigator, might compromise the study or confound the study results * History of use of any anti-inflammatory biologics * History of or current splenomegaly (related to possible risk of G-CSF) * History of sickle cell disease (related to possible risk of G-CSF) * High risk for medical complications that might affect the subject's ability to complete the trial without a serious co-morbid event, based on medical history, physical examination and laboratory screening evaluation in the opinion of the Investigator * Presence of an acute or chronic condition (such as a hematological, rheumatologic auto-immune disease, chronic inflammatory disorder or osteoporosis) based on history, clinical, or laboratory evaluation, which, in the opinion of the Investigator, might compromise the study, confound the study results or place the subject at risk * Follicle stimulating hormone (FSH) \< 40 IU/L or below the reference range for menopause for the local laboratory used for screening * Thyroid stimulating hormone (TSH) outside normal limits at study entry * Absolute neutrophil count (ANC) ≤ 1.0 x 109/L * Total white blood cell count (WBC) ≤ 3.0 x 109/L * Platelet count (PLT) ≤ 150 x 109/L * Hemoglobin count (HGB) consistent with anemia * Positive urine pregnancy test at Baseline visit * Allergy or hypersensitivity to E coli-derived proteins' G-CSF' or any component of the product * Mentally or legally incapacitated such that informed consent cannot be obtained * Inability or unwillingness to complete daily hot flash diary and study questionnaires appropriately * Participation in another investigational trial within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 12 | Baseline and week 12 | HFSS (Daily Hot Flash Severity Score) was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. |
| Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0 | Baseline and day 1 | Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 0. Blood samples were collected 24 hours after adminstration of G-CSF on day 0. |
| Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 28 | Baseline and day 29 | Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 28. Blood samples were collected 24 hours after adminstration of G-CSF on day 28. |
| Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 56. | Baseline and day 57 | Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 56. Blood samples were collected 24 hours after adminstration of G-CSF on day 56. |
| Change From Baseline in White Blood Cell Counts on Day 84 (28 Days After Last Administration of G-CSF or Palcebo) | Baseline and day 84 | Change from baseline in white blood cell counts on day 84. Blood samples were collected 24 hours after adminstration of G-CSF on day 84. |
| Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 4 | Baseline and week 4 | The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. |
| Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 12 | Baseline and week 12 | The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. |
| Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 4 | Baseline and week 4 | CDS (Composite Daily Hot Flash Severity) was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. |
| Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 12 | Baseline and week 12 | CDS (Composite Daily Hot Flash Severity) was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. |
| Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 4 | Baseline and week 4 | HFSS (Daily Hot Flash Severity Score) was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. |
| Number of Participants With Adverse Events | From first dose date up to 30 days after last dose (up to 16 weeks) | An adverse event (AE) is any untoward medical occurrence, including the exacerbation of a pre-existing condition, in a subject or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution. This includes any experience that results in death; is acutely life-threatening; requires inpatient hospitalization or prolongs the existing hospitalization; results in persistent or significant incapacity or substantial disruption of ability to conduct normal life functions; is a congenital anomaly/birth defect; or requires medical or surgical intervention to prevent one of the outcomes listed above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Weeks 1-12 | CDS was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. |
| Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Weeks 1-12 | HFSS was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]. HFSS = ((number of daily mild hot flashes x1) + (number of daily moderate hot flashes x2) + (number of severe hot flashes x3))/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe (S) hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. Severity was zero for participants that had no mild or moderate or severe VMS. Higher scores indicates greater severity. |
| Percent Change in M+S at 12 Weeks in Demographic Subgroups | Baseline and Week 12 | The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. |
| Net Change in HFSS at 12 Weeks in Demographic Subgroups | Baseline and Week 12 | HFSS (Daily Hot Flash Severity Score) was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]. HFSS = ((number of daily mild hot flashes x1) + (number of daily moderate hot flashes x2) + (number of severe hot flashes x3))/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe (S) hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received |
| Net Change in MENQOL VMS Score | Baseline and week 12 | Menopause-specific Quality of Life (MENQOL) Questionnaire. The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). MENQOL VMS refers to the answers to items 1-3 where 6 = most bothersome and 0 = least bothersome). (Maximum bothersomeness = 18; No bothersomeness = 0) |
| Net Change in HFRDIS Score | Baseline and week 12 | The Hot Flash Related Daily Interference Scale (HFRDIS) measures (as a score of 0 to 10) the effect of hot flashes on overall quality of life and on nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, and enjoyment of life. The 10 answers are added up to get a total score. HFRDIS Score (Maximum Bothersomness = 100; No Bothersomeness = 0). The higher the score, the more bothersome the symptoms. |
| Net Change in ISI Score at 12 Weeks | Baseline and week 12 | The Insomnia Severity Index has seven questions. For each question, most bothersome = 4; not bothersome = 0. The seven answers are added up to get a total score. Total score categories: 0-7 = No clinically significant insomnia; 8-14 = Subthreshold insomnia; 15-21 = Clinical insomnia (moderate severity); 22-28 = Clinical insomnia (severe) |
| Net Change in FSS Score at 12 Weeks | Baseline and week 12 | Fatigue Severity Scale (FSS) of Sleep Disorders. The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue. The FSS is a short questionnaire (10 questions) that requires the subject to rate level of fatigue. The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. Each statement is read and the corresponding number from 1 to 7 is circled. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. (Maximum bother = 70; No bother = 0) |
| Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Weeks 1-12 | The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. |
Countries
United States
Participant flow
Recruitment details
Postmenopausal women participants 40 to 65 years of age who had moderate to severe vasomotor symptoms (VMS) and seeking treatment or relief for hot flashes associated with menopause, confirmed as menopausal, had to have 7 to 8 moderate to severe hot flashes per day within the 7 days prior to randomization and who met the inclusion criteria and none of the exclusion criteria were enrolled in this study. A total of 61 subjects were randomized to receive G-CSF or saline in this trial.
Pre-assignment details
Prior to randomization, participants had a screening period during which a minimum 7-day collection of baseline hot flash frequency and severity assessments were performed.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: G-CSF (All Subjects) Intervention: G-CSF given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Filgrastim
G-CSF: G-CSF injected subcutaneously 3 times (Days 0, 28, 56) | 31 |
| Comparator: Placebo/Saline (All Subjects) Intervention: Placebo/saline given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Saline
Placebo/Saline: Placebo/saline injected subcutaneously 3 times (Days 0, 28, 56) | 30 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Experimental: G-CSF (All Subjects) | Comparator: Placebo/Saline (All Subjects) |
|---|---|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 4.45 | 55.4 years STANDARD_DEVIATION 4.39 | 55.6 years STANDARD_DEVIATION 4.58 |
| Composite Daily Hot Flash Severity (CDS) | 33.7 Number of hot flashes per day STANDARD_DEVIATION 13.49 | 33.7 Number of hot flashes per day STANDARD_DEVIATION 12.72 | 33.7 Number of hot flashes per day STANDARD_DEVIATION 14.44 |
| Daily Moderate + Severe Hot Flashes (M+S) | 12.4 Number of hot flashes per day STANDARD_DEVIATION 4.9 | 12.5 Number of hot flashes per day STANDARD_DEVIATION 5.14 | 12.3 Number of hot flashes per day STANDARD_DEVIATION 4.73 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 25 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fatigue Severity Scale (FSS) Score | 33.9 Score on a scale STANDARD_DEVIATION 15.5 | 33.8 Score on a scale STANDARD_DEVIATION 15.6 | 34.0 Score on a scale STANDARD_DEVIATION 15.8 |
| Hot Flash Related Daily Interference Scale (HFRDIS) Score | 59.8 Score on a scale STANDARD_DEVIATION 20.2 | 56.9 Score on a scale STANDARD_DEVIATION 21.5 | 62.6 Score on a scale STANDARD_DEVIATION 18.7 |
| Hot Flash Severity Score (HFSS) | 2.3 Score on a scale STANDARD_DEVIATION 0.34 | 2.3 Score on a scale STANDARD_DEVIATION 0.32 | 2.4 Score on a scale STANDARD_DEVIATION 0.35 |
| Insomnia Severity Index (ISI) Score | 19.1 Score on a scale STANDARD_DEVIATION 5.2 | 18.8 Score on a scale STANDARD_DEVIATION 5.1 | 19.4 Score on a scale STANDARD_DEVIATION 5.4 |
| Menopause-specific Quality of Life Questionnaire - Vasomotor symptom (MENQOL VMS) Score | 15.6 Score on a scale STANDARD_DEVIATION 2.5 | 15.5 Score on a scale STANDARD_DEVIATION 2.6 | 15.6 Score on a scale STANDARD_DEVIATION 2.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 22 Participants | 23 Participants |
| Sex: Female, Male Female | 61 Participants | 31 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| White Blood Cell Counts (WBC) | 6088 White Blood Cells per mL STANDARD_DEVIATION 1633 | 6007 White Blood Cells per mL STANDARD_DEVIATION 1923 | 6142 White Blood Cells per mL STANDARD_DEVIATION 1296 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 24 / 30 | 20 / 30 | 12 / 18 | 10 / 18 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 12
CDS (Composite Daily Hot Flash Severity) was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Time frame: Baseline and week 12
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Experimental: G-CSF (All Subjects) | Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 12 | -17 Number of hot flashes per day |
| Comparator: Placebo/Saline (All Subjects) | Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 12 | -16 Number of hot flashes per day |
| Experimental: G-CSF (White, NH Subgroup) | Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 12 | -19 Number of hot flashes per day |
| Comparator: Placebo/Saline (White, NH Subgroup) | Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 12 | -12 Number of hot flashes per day |
p-value: 0.333Mixed Models Analysis
p-value: 0.014Mixed Models Analysis
Primary
Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 4
CDS (Composite Daily Hot Flash Severity) was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Time frame: Baseline and week 4
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Experimental: G-CSF (All Subjects) | Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 4 | -10 Number of hot flashes per day |
| Comparator: Placebo/Saline (All Subjects) | Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 4 | -11 Number of hot flashes per day |
| Experimental: G-CSF (White, NH Subgroup) | Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 4 | -11 Number of hot flashes per day |
| Comparator: Placebo/Saline (White, NH Subgroup) | Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 4 | -10 Number of hot flashes per day |
p-value: 0.501Mixed Models Analysis
p-value: 0.37Mixed Models Analysis
Primary
Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 12
HFSS (Daily Hot Flash Severity Score) was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Time frame: Baseline and week 12
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Experimental: G-CSF (All Subjects) | Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 12 | -0.31 Hot flash severity score |
| Comparator: Placebo/Saline (All Subjects) | Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 12 | -0.13 Hot flash severity score |
| Experimental: G-CSF (White, NH Subgroup) | Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 12 | -0.43 Hot flash severity score |
| Comparator: Placebo/Saline (White, NH Subgroup) | Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 12 | -0.19 Hot flash severity score |
p-value: 0.032Mixed Models Analysis
p-value: 0.077Mixed Models Analysis
Primary
Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 4
HFSS (Daily Hot Flash Severity Score) was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Time frame: Baseline and week 4
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Experimental: G-CSF (All Subjects) | Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 4 | -0.09 Hot flash severity score |
| Comparator: Placebo/Saline (All Subjects) | Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 4 | -0.08 Hot flash severity score |
| Experimental: G-CSF (White, NH Subgroup) | Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 4 | -0.11 Hot flash severity score |
| Comparator: Placebo/Saline (White, NH Subgroup) | Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 4 | -0.07 Hot flash severity score |
p-value: 0.124Mixed Models Analysis
p-value: 0.175Mixed Models Analysis
Primary
Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 12
The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Time frame: Baseline and week 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Experimental: G-CSF (All Subjects) | Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 12 | -6.4 Number of hot flashes per day |
| Comparator: Placebo/Saline (All Subjects) | Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 12 | -6.0 Number of hot flashes per day |
| Experimental: G-CSF (White, NH Subgroup) | Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 12 | -7.5 Number of hot flashes per day |
| Comparator: Placebo/Saline (White, NH Subgroup) | Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 12 | -4.5 Number of hot flashes per day |
Comparison: Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariatesp-value: 0.232Mixed Models Analysis
Comparison: Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariatesp-value: 0.085Mixed Models Analysis
Primary
Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 4
The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Time frame: Baseline and week 4
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Experimental: G-CSF (All Subjects) | Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 4 | -3.9 Number of hot flashes per day |
| Comparator: Placebo/Saline (All Subjects) | Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 4 | -4.0 Number of hot flashes per day |
| Experimental: G-CSF (White, NH Subgroup) | Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 4 | -4.1 Number of hot flashes per day |
| Comparator: Placebo/Saline (White, NH Subgroup) | Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 4 | -4.0 Number of hot flashes per day |
p-value: 0.398Mixed Models Analysis
p-value: 0.391Mixed Models Analysis
Primary
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0
Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 0. Blood samples were collected 24 hours after adminstration of G-CSF on day 0.
Time frame: Baseline and day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0 | 17493 Number of white blood cells per mL | Standard Error 822 |
| Comparator: Placebo/Saline (All Subjects) | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0 | 103 Number of white blood cells per mL | Standard Error 144 |
| Experimental: G-CSF (White, NH Subgroup) | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0 | 17394 Number of white blood cells per mL | Standard Error 1095 |
| Comparator: Placebo/Saline (White, NH Subgroup) | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0 | 144 Number of white blood cells per mL | Standard Error 210 |
p-value: <0.001t-test, 1 sided
p-value: <0.001t-test, 1 sided
Primary
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 28
Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 28. Blood samples were collected 24 hours after adminstration of G-CSF on day 28.
Time frame: Baseline and day 29
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 28 | 18273 Number of white blood cells per mL | Standard Error 988 |
| Comparator: Placebo/Saline (All Subjects) | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 28 | 13 Number of white blood cells per mL | Standard Error 182 |
| Experimental: G-CSF (White, NH Subgroup) | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 28 | 18378 Number of white blood cells per mL | Standard Error 1147 |
| Comparator: Placebo/Saline (White, NH Subgroup) | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 28 | 67 Number of white blood cells per mL | Standard Error 230 |
p-value: <0.001t-test, 1 sided
p-value: <0.001t-test, 1 sided
Primary
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 56.
Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 56. Blood samples were collected 24 hours after adminstration of G-CSF on day 56.
Time frame: Baseline and day 57
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 56. | 16403 Number of white blood cells per mL | Standard Error 1445 |
| Comparator: Placebo/Saline (All Subjects) | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 56. | 37 Number of white blood cells per mL | Standard Error 208 |
| Experimental: G-CSF (White, NH Subgroup) | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 56. | 15128 Number of white blood cells per mL | Standard Error 2112 |
| Comparator: Placebo/Saline (White, NH Subgroup) | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 56. | 150 Number of white blood cells per mL | Standard Error 340 |
p-value: <0.001t-test, 1 sided
p-value: <0.001t-test, 1 sided
Primary
Change From Baseline in White Blood Cell Counts on Day 84 (28 Days After Last Administration of G-CSF or Palcebo)
Change from baseline in white blood cell counts on day 84. Blood samples were collected 24 hours after adminstration of G-CSF on day 84.
Time frame: Baseline and day 84
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Change From Baseline in White Blood Cell Counts on Day 84 (28 Days After Last Administration of G-CSF or Palcebo) | -107 Number of white blood cells per mL | Standard Error 311 |
| Comparator: Placebo/Saline (All Subjects) | Change From Baseline in White Blood Cell Counts on Day 84 (28 Days After Last Administration of G-CSF or Palcebo) | -420 Number of white blood cells per mL | Standard Error 311 |
| Experimental: G-CSF (White, NH Subgroup) | Change From Baseline in White Blood Cell Counts on Day 84 (28 Days After Last Administration of G-CSF or Palcebo) | -611 Number of white blood cells per mL | Standard Error 297 |
| Comparator: Placebo/Saline (White, NH Subgroup) | Change From Baseline in White Blood Cell Counts on Day 84 (28 Days After Last Administration of G-CSF or Palcebo) | -256 Number of white blood cells per mL | Standard Error 265 |
p-value: 0.199t-test, 1 sided
p-value: 0.189t-test, 1 sided
Primary
Number of Participants With Adverse Events
An adverse event (AE) is any untoward medical occurrence, including the exacerbation of a pre-existing condition, in a subject or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution. This includes any experience that results in death; is acutely life-threatening; requires inpatient hospitalization or prolongs the existing hospitalization; results in persistent or significant incapacity or substantial disruption of ability to conduct normal life functions; is a congenital anomaly/birth defect; or requires medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: From first dose date up to 30 days after last dose (up to 16 weeks)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Number of Participants With Adverse Events | Treatment Emergent Adverse Events (TEAE) | 24 Participants |
| Experimental: G-CSF (All Subjects) | Number of Participants With Adverse Events | Drug-related TEAE | 12 Participants |
| Experimental: G-CSF (All Subjects) | Number of Participants With Adverse Events | Serious TEAE | 0 Participants |
| Experimental: G-CSF (All Subjects) | Number of Participants With Adverse Events | Drug-related serious TEAE | 0 Participants |
| Experimental: G-CSF (All Subjects) | Number of Participants With Adverse Events | TEAE leading to death | 0 Participants |
| Experimental: G-CSF (All Subjects) | Number of Participants With Adverse Events | TEAE leading to withdrawal of treatment | 0 Participants |
| Comparator: Placebo/Saline (All Subjects) | Number of Participants With Adverse Events | TEAE leading to withdrawal of treatment | 0 Participants |
| Comparator: Placebo/Saline (All Subjects) | Number of Participants With Adverse Events | Drug-related serious TEAE | 0 Participants |
| Comparator: Placebo/Saline (All Subjects) | Number of Participants With Adverse Events | Treatment Emergent Adverse Events (TEAE) | 20 Participants |
| Comparator: Placebo/Saline (All Subjects) | Number of Participants With Adverse Events | Serious TEAE | 0 Participants |
| Comparator: Placebo/Saline (All Subjects) | Number of Participants With Adverse Events | Drug-related TEAE | 3 Participants |
| Comparator: Placebo/Saline (All Subjects) | Number of Participants With Adverse Events | TEAE leading to death | 0 Participants |
| Experimental: G-CSF (White, NH Subgroup) | Number of Participants With Adverse Events | Drug-related TEAE | 5 Participants |
| Experimental: G-CSF (White, NH Subgroup) | Number of Participants With Adverse Events | Serious TEAE | 0 Participants |
| Experimental: G-CSF (White, NH Subgroup) | Number of Participants With Adverse Events | Drug-related serious TEAE | 0 Participants |
| Experimental: G-CSF (White, NH Subgroup) | Number of Participants With Adverse Events | TEAE leading to withdrawal of treatment | 0 Participants |
| Experimental: G-CSF (White, NH Subgroup) | Number of Participants With Adverse Events | TEAE leading to death | 0 Participants |
| Experimental: G-CSF (White, NH Subgroup) | Number of Participants With Adverse Events | Treatment Emergent Adverse Events (TEAE) | 12 Participants |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Participants With Adverse Events | TEAE leading to death | 0 Participants |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Participants With Adverse Events | TEAE leading to withdrawal of treatment | 0 Participants |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Participants With Adverse Events | Drug-related TEAE | 3 Participants |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Participants With Adverse Events | Drug-related serious TEAE | 0 Participants |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Participants With Adverse Events | Treatment Emergent Adverse Events (TEAE) | 10 Participants |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Participants With Adverse Events | Serious TEAE | 0 Participants |
Secondary
Net Change in FSS Score at 12 Weeks
Fatigue Severity Scale (FSS) of Sleep Disorders. The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue. The FSS is a short questionnaire (10 questions) that requires the subject to rate level of fatigue. The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. Each statement is read and the corresponding number from 1 to 7 is circled. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. (Maximum bother = 70; No bother = 0)
Time frame: Baseline and week 12
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Net Change in FSS Score at 12 Weeks | -5.3 score on a scale | Standard Error 3 |
| Comparator: Placebo/Saline (All Subjects) | Net Change in FSS Score at 12 Weeks | -6.2 score on a scale | Standard Error 2.2 |
| Experimental: G-CSF (White, NH Subgroup) | Net Change in FSS Score at 12 Weeks | -6.9 score on a scale | Standard Error 3.7 |
| Comparator: Placebo/Saline (White, NH Subgroup) | Net Change in FSS Score at 12 Weeks | -7.0 score on a scale | Standard Error 2.8 |
p-value: 0.406t-test, 1 sided
p-value: 0.494t-test, 1 sided
Secondary
Net Change in HFRDIS Score
The Hot Flash Related Daily Interference Scale (HFRDIS) measures (as a score of 0 to 10) the effect of hot flashes on overall quality of life and on nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, and enjoyment of life. The 10 answers are added up to get a total score. HFRDIS Score (Maximum Bothersomness = 100; No Bothersomeness = 0). The higher the score, the more bothersome the symptoms.
Time frame: Baseline and week 12
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Net Change in HFRDIS Score | -22.5 score on a scale | Standard Error 6.1 |
| Comparator: Placebo/Saline (All Subjects) | Net Change in HFRDIS Score | -26.7 score on a scale | Standard Error 4.5 |
| Experimental: G-CSF (White, NH Subgroup) | Net Change in HFRDIS Score | -21.2 score on a scale | Standard Error 7.7 |
| Comparator: Placebo/Saline (White, NH Subgroup) | Net Change in HFRDIS Score | -25.1 score on a scale | Standard Error 5 |
p-value: 0.338t-test, 1 sided
p-value: 0.289t-test, 1 sided
Secondary
Net Change in HFSS at 12 Weeks in Demographic Subgroups
HFSS (Daily Hot Flash Severity Score) was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]. HFSS = ((number of daily mild hot flashes x1) + (number of daily moderate hot flashes x2) + (number of severe hot flashes x3))/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe (S) hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received
Time frame: Baseline and Week 12
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Net Change in HFSS at 12 Weeks in Demographic Subgroups | -0.29 Hot flash severity score | Standard Error 0.16 |
| Comparator: Placebo/Saline (All Subjects) | Net Change in HFSS at 12 Weeks in Demographic Subgroups | -0.09 Hot flash severity score | Standard Error 0.11 |
| Experimental: G-CSF (White, NH Subgroup) | Net Change in HFSS at 12 Weeks in Demographic Subgroups | 0.13 Hot flash severity score | Standard Error 0.14 |
| Comparator: Placebo/Saline (White, NH Subgroup) | Net Change in HFSS at 12 Weeks in Demographic Subgroups | -0.13 Hot flash severity score | Standard Error 0.2 |
| Experimental: G-CSF (Black Subjects) | Net Change in HFSS at 12 Weeks in Demographic Subgroups | -0.14 Hot flash severity score | Standard Error 0.1 |
| Comparator: Placebo (Black Subjects) | Net Change in HFSS at 12 Weeks in Demographic Subgroups | 0.13 Hot flash severity score | Standard Error 0.21 |
p-value: 0.147t-test, 1 sided
p-value: 0.16t-test, 1 sided
p-value: 0.152t-test, 1 sided
Secondary
Net Change in ISI Score at 12 Weeks
The Insomnia Severity Index has seven questions. For each question, most bothersome = 4; not bothersome = 0. The seven answers are added up to get a total score. Total score categories: 0-7 = No clinically significant insomnia; 8-14 = Subthreshold insomnia; 15-21 = Clinical insomnia (moderate severity); 22-28 = Clinical insomnia (severe)
Time frame: Baseline and week 12
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Net Change in ISI Score at 12 Weeks | -5.5 score on a scale | Standard Error 1.5 |
| Comparator: Placebo/Saline (All Subjects) | Net Change in ISI Score at 12 Weeks | -6.0 score on a scale | Standard Error 1.1 |
| Experimental: G-CSF (White, NH Subgroup) | Net Change in ISI Score at 12 Weeks | -4.6 score on a scale | Standard Error 2 |
| Comparator: Placebo/Saline (White, NH Subgroup) | Net Change in ISI Score at 12 Weeks | -3.8 score on a scale | Standard Error 1.4 |
p-value: 0.393t-test, 1 sided
p-value: 0.365t-test, 1 sided
Secondary
Net Change in MENQOL VMS Score
Menopause-specific Quality of Life (MENQOL) Questionnaire. The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). MENQOL VMS refers to the answers to items 1-3 where 6 = most bothersome and 0 = least bothersome). (Maximum bothersomeness = 18; No bothersomeness = 0)
Time frame: Baseline and week 12
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Net Change in MENQOL VMS Score | -5.7 Score on a scale | Standard Error 1 |
| Comparator: Placebo/Saline (All Subjects) | Net Change in MENQOL VMS Score | -4.8 Score on a scale | Standard Error 1.2 |
| Experimental: G-CSF (White, NH Subgroup) | Net Change in MENQOL VMS Score | -6.0 Score on a scale | Standard Error 1.2 |
| Comparator: Placebo/Saline (White, NH Subgroup) | Net Change in MENQOL VMS Score | -3.6 Score on a scale | Standard Error 1.5 |
p-value: 0.286t-test, 1 sided
p-value: 0.107t-test, 1 sided
Secondary
Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12
HFSS was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]. HFSS = ((number of daily mild hot flashes x1) + (number of daily moderate hot flashes x2) + (number of severe hot flashes x3))/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe (S) hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. Severity was zero for participants that had no mild or moderate or severe VMS. Higher scores indicates greater severity.
Time frame: Weeks 1-12
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 10 | 8 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 12 | 7 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 8 | 7 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 1 | 4 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 9 | 9 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 3 | 7 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 4 | 5 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 2 | 4 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 11 | 9 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 5 | 6 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 6 | 8 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 7 | 7 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 2 | 5 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 7 | 6 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 4 | 6 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 9 | 5 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 10 | 4 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 8 | 6 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 1 | 4 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 6 | 5 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 5 | 6 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 3 | 6 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 12 | 6 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 11 | 5 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 8 | 5 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 1 | 2 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 2 | 3 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 3 | 4 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 4 | 3 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 5 | 3 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 6 | 6 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 7 | 5 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 9 | 7 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 10 | 6 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 11 | 6 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 12 | 6 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 6 | 3 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 5 | 4 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 1 | 3 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 10 | 2 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 4 | 4 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 3 | 4 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 12 | 3 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 11 | 3 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 8 | 4 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 7 | 4 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 2 | 2 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | Week 9 | 3 Number of subjects |
Secondary
Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12
CDS was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Time frame: Weeks 1-12
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 10 | 13 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 12 | 15 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 8 | 12 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 1 | 5 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 9 | 14 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 3 | 7 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 4 | 7 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 2 | 8 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 11 | 15 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 5 | 15 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 6 | 14 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 7 | 15 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 2 | 7 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 7 | 11 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 4 | 7 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 9 | 11 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 10 | 12 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 8 | 11 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 1 | 4 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 6 | 13 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 5 | 9 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 3 | 8 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 12 | 13 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 11 | 13 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 8 | 7 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 1 | 2 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 2 | 5 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 3 | 5 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 4 | 4 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 5 | 10 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 6 | 10 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 7 | 10 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 9 | 8 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 10 | 8 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 11 | 9 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 12 | 9 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 6 | 6 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 5 | 3 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 1 | 3 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 10 | 5 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 4 | 4 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 3 | 4 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 12 | 5 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 11 | 6 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 8 | 4 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 7 | 5 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 2 | 3 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | Week 9 | 5 Number of subjects |
Secondary
Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12
The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Time frame: Weeks 1-12
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.~Outcome Measure Data Table \* Measure Type: Least Squares Mean~\* Measure ofDispersion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 10 | 14 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 12 | 15 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 8 | 12 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 1 | 5 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 9 | 15 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 3 | 7 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 4 | 8 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 2 | 8 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 11 | 15 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 5 | 15 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 6 | 15 Number of subjects |
| Experimental: G-CSF (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 7 | 15 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 2 | 7 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 7 | 12 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 4 | 8 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 9 | 10 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 10 | 12 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 8 | 13 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 1 | 4 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 6 | 12 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 5 | 9 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 3 | 9 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 12 | 14 Number of subjects |
| Comparator: Placebo/Saline (All Subjects) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 11 | 13 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 8 | 7 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 1 | 2 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 2 | 5 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 3 | 5 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 4 | 5 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 5 | 10 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 6 | 10 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 7 | 10 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 9 | 9 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 10 | 9 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 11 | 9 Number of subjects |
| Experimental: G-CSF (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 12 | 9 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 6 | 5 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 5 | 3 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 1 | 3 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 10 | 5 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 4 | 4 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 3 | 4 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 12 | 6 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 11 | 6 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 8 | 5 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 7 | 5 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 2 | 3 Number of subjects |
| Comparator: Placebo/Saline (White, NH Subgroup) | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | Week 9 | 4 Number of subjects |
Secondary
Percent Change in M+S at 12 Weeks in Demographic Subgroups
The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Time frame: Baseline and Week 12
Population: Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: G-CSF (All Subjects) | Percent Change in M+S at 12 Weeks in Demographic Subgroups | -51 Percent change in hot flashes | Standard Error 8 |
| Comparator: Placebo/Saline (All Subjects) | Percent Change in M+S at 12 Weeks in Demographic Subgroups | -33 Percent change in hot flashes | Standard Error 8 |
| Experimental: G-CSF (White, NH Subgroup) | Percent Change in M+S at 12 Weeks in Demographic Subgroups | -32 Percent change in hot flashes | Standard Error 18 |
| Comparator: Placebo/Saline (White, NH Subgroup) | Percent Change in M+S at 12 Weeks in Demographic Subgroups | -62 Percent change in hot flashes | Standard Error 15 |
| Experimental: G-CSF (Black Subjects) | Percent Change in M+S at 12 Weeks in Demographic Subgroups | -46 Percent change in hot flashes | Standard Error 18 |
| Comparator: Placebo (Black Subjects) | Percent Change in M+S at 12 Weeks in Demographic Subgroups | -55 Percent change in hot flashes | Standard Error 14 |
p-value: 0.047t-test, 1 sided
p-value: 0.139t-test, 1 sided
p-value: 0.395t-test, 1 sided