A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women
Condition: Postmenopausal Symptoms
MeSH terms: Hot Flashes
Intervention: G-CSF; Placebo/Saline
Intervention description: G-CSF injected subcutaneously 3 times (Days 0, 28, 56); Placebo/saline injected subcutaneously 3 times (Days 0, 28, 56)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hot Flashes; Vasomotor Symptoms; Menopause

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.
    

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