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

Primary Purpose

Postmenopausal Symptoms

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

G-CSF

Placebo/Saline

About this trial

This is an interventional treatment trial for Postmenopausal Symptoms focused on measuring Hot Flashes, Vasomotor Symptoms, Menopause

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Site 2
Site 1

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental: G-CSF

Comparator: Placebo/Saline

Arm Description

Intervention: G-CSF given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Filgrastim

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

Outcomes

Primary Outcome Measures

Safety as assessed by the number of adverse events following repeated subcutaneous injection of G-CSF

Secondary Outcome Measures

Circulating white blood cells concentrations as measured by change from baseline.

Circulating hormone concentrations as measured by change from baseline.

Circulating inflammatory cytokine concentrations as measured by change from baseline.

Change from baseline in the average daily frequency of mild, moderate and severe hot flashes at Weeks 2, 4, 6, 8, 10 and 12

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

Full Information

NCT ID

NCT03640754

First Posted

July 30, 2018

Last Updated

April 4, 2022

Sponsor

MenoGeniX, Inc.

Collaborators

National Institutes of Health (NIH), National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT03640754

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

August 6, 2018 (Actual)

Primary Completion Date

January 21, 2022 (Actual)

Study Completion Date

February 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MenoGeniX, Inc.

Collaborators

National Institutes of Health (NIH), National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postmenopausal Symptoms

Keywords

Hot Flashes, Vasomotor Symptoms, Menopause

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: G-CSF

Arm Type

Active Comparator

Arm Description

Intervention: G-CSF given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Filgrastim

Arm Title

Comparator: Placebo/Saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

G-CSF

Other Intervention Name(s)

Filgrastim

Intervention Description

G-CSF injected subcutaneously 3 times (Days 0, 28, 56)

Intervention Type

Other

Intervention Name(s)

Placebo/Saline

Other Intervention Name(s)

Saline

Intervention Description

Placebo/saline injected subcutaneously 3 times (Days 0, 28, 56)

Primary Outcome Measure Information:

Title

Safety as assessed by the number of adverse events following repeated subcutaneous injection of G-CSF

Time Frame

Baseline to Weeks 12

Secondary Outcome Measure Information:

Title

Circulating white blood cells concentrations as measured by change from baseline.

Time Frame

Baseline to Week 12

Title

Circulating hormone concentrations as measured by change from baseline.

Time Frame

Baseline to Week 12

Title

Circulating inflammatory cytokine concentrations as measured by change from baseline.

Time Frame

Baseline to Week 12

Title

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

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard C Duke, PhD

Organizational Affiliation

MenoGeniX, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Site 2

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Site 1

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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