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Phase 1 Completed N=61 Randomized Triple-blind Treatment

A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women

Postmenopausal Symptoms
Source: ClinicalTrials.gov NCT03640754 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Number of Participants With Adverse Events — 24; 20; 12; 10 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Adverse Events		 24; 20; 12; 10; 12; 3 —
PRIMARY
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0		 17493; 103; 17394; 144 <0.001 sig
PRIMARY
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 28		 18273; 13; 18378; 67 <0.001 sig
PRIMARY
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 56.		 16403; 37; 15128; 150 <0.001 sig
PRIMARY
Change From Baseline in White Blood Cell Counts on Day 84 (28 Days After Last Administration of G-CSF or Palcebo)		 -107; -420; -611; -256 0.199
PRIMARY
Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 4		 -3.9; -4.0; -4.1; -4.0 0.398
PRIMARY
Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 12		 -6.4; -6.0; -7.5; -4.5 0.232
PRIMARY
Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 4		 -10; -11; -11; -10 0.501
PRIMARY
Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 12		 -17; -16; -19; -12 0.333
PRIMARY
Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 4		 -0.09; -0.08; -0.11; -0.07 0.124
PRIMARY
Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 12		 -0.31; -0.13; -0.43; -0.19 0.032 sig
SECONDARY
Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12		 5; 4; 2; 3; 8; 7 —
SECONDARY
Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12		 5; 4; 2; 3; 8; 7 —
SECONDARY
Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12		 4; 4; 2; 3; 4; 5 —
SECONDARY
Percent Change in M+S at 12 Weeks in Demographic Subgroups		 -51; -33; -32; -62; -46; -55 0.047 sig
SECONDARY
Net Change in HFSS at 12 Weeks in Demographic Subgroups		 -0.29; -0.09; 0.13; -0.13; -0.14; 0.13 0.147
SECONDARY
Net Change in MENQOL VMS Score		 -5.7; -4.8; -6.0; -3.6 0.286
SECONDARY
Net Change in HFRDIS Score		 -22.5; -26.7; -21.2; -25.1 0.289
SECONDARY
Net Change in ISI Score at 12 Weeks		 -5.5; -6.0; -4.6; -3.8 0.393
SECONDARY
Net Change in FSS Score at 12 Weeks		 -5.3; -6.2; -6.9; -7.0 0.406

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03640754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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