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

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ClinicalTrials.gov Identifier: NCT03640754
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
MenoGeniX, Inc.

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Symptoms Biological: G-CSF Other: Placebo/Saline Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study to Assess the Safety and Effect of Repeated Administration of Granulocyte Colony-Stimulating Factor (G-CSF; Filgrastim) on Hot Flashes and Other Vasomotor Symptoms of Menopause in Postmenopausal Women
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : August 6, 2019
Estimated Study Completion Date : September 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Active Comparator: Experimental: G-CSF
Intervention: G-CSF given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Filgrastim
Biological: G-CSF
G-CSF injected subcutaneously 3 times (Days 0, 28, 56)
Other Name: Filgrastim

Placebo Comparator: Comparator: Placebo/Saline
Intervention: Placebo/saline given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Saline
Other: Placebo/Saline
Placebo/saline injected subcutaneously 3 times (Days 0, 28, 56)
Other Name: Saline




Primary Outcome Measures :
  1. Safety as assessed by the number of adverse events following repeated subcutaneous injection of G-CSF [ Time Frame: Baseline to Weeks 12 ]

Secondary Outcome Measures :
  1. Circulating white blood cells concentrations as measured by change from baseline. [ Time Frame: Baseline to Week 12 ]
  2. Circulating hormone concentrations as measured by change from baseline. [ Time Frame: Baseline to Week 12 ]
  3. Circulating inflammatory cytokine concentrations as measured by change from baseline. [ Time Frame: Baseline to Week 12 ]
  4. Change from baseline in the average daily frequency of mild, moderate and severe hot flashes at Weeks 2, 4, 6, 8, 10 and 12 [ Time Frame: Weeks 2, 4, 6, 8, 10 and 12 ]
  5. Change from baseline in the average daily severity score of mild, moderate and severe hot flashes at Weeks 2, 4, 6, 8, 10 and 12 [ Time Frame: Weeks 2, 4, 6, 8, 10 and 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640754


Contacts
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Contact: Cynthia Schechter cynthia.schechter@menogenix.com
Contact: Debra Duke debra.duke@menogenix.com

Locations
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United States, Colorado
Site 2 Not yet recruiting
Aurora, Colorado, United States, 80045
Site 1 Recruiting
Denver, Colorado, United States, 80209
Sponsors and Collaborators
MenoGeniX, Inc.
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
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Study Chair: Richard C Duke, PhD MenoGeniX, Inc.

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Responsible Party: MenoGeniX, Inc.
ClinicalTrials.gov Identifier: NCT03640754     History of Changes
Other Study ID Numbers: MNGX-102
1R43AG056209-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by MenoGeniX, Inc.:
Hot Flashes
Vasomotor Symptoms
Menopause
Additional relevant MeSH terms:
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Hot Flashes
Signs and Symptoms
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs