Postmenopausal SymptomsPhase 1NCT03640754
A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women
A Phase 1 study testing G-CSF in people with Postmenopausal Symptoms, run by MenoGeniX, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Postmenopausal Symptoms
- What is being tested?
- G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Aug 2018to 22 Feb 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 30Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site 2
Aurora, Colorado, 80045
Site 1
Denver, Colorado, 80209
About this study
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
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.
Read the 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.
- Conditions
- Postmenopausal Symptoms
- Being tested
- G-CSF, Placebo/Saline
- Keywords
- Hot Flashes, Vasomotor Symptoms, Menopause
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSFBiological
Also called Filgrastim
G-CSF injected subcutaneously 3 times (Days 0, 28, 56)
Placebo/SalineOther
Also called Saline
Placebo/saline injected subcutaneously 3 times (Days 0, 28, 56)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: G-CSF | Active comparator | Intervention: G-CSF given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Filgrastim Receives: Biological: G-CSF |
| Comparator: Placebo/Saline | Placebo comparator | Intervention: Placebo/saline given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Saline Receives: Other: Placebo/Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first dose date up to 30 days after last dose (up to 16 weeks)
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.
Measured: Baseline and day 1
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.
Measured: Baseline and day 29
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.
Measured: Baseline and day 57
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.
Measured: Baseline and day 84
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.
Measured: Baseline and week 4
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.
Measured: Baseline and week 12
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.
Measured: Baseline and week 4
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.
Measured: Baseline and week 12
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.
Measured: Baseline and week 4
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.
Measured: Baseline and week 12
Secondary outcomes (9)
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.
Measured: Weeks 1-12
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.
Measured: Weeks 1-12
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.
Measured: Weeks 1-12
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.
Measured: Baseline and Week 12
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
Measured: Baseline and Week 12
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)
Measured: Baseline and week 12
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.
Measured: Baseline and week 12
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)
Measured: Baseline and week 12
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)
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start6 Aug 2018
- Primary completion21 Jan 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postmenopausal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- MenoGeniX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Richard C Duke, PhD, Study chair, MenoGeniX, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640754
- Sponsor's protocol ID
- MNGX-102
- Other IDs
- 1R43AG056209-01A1
- Status last verified
- Nov 2023
- First submitted
- 30 Jul 2018
- Last updated
- 28 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03640754
- Acronym / sponsor ID
- MNGX-102
- Conditions
- Postmenopausal Symptoms
- Keywords
- Hot Flashes, Vasomotor Symptoms, Menopause
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- MenoGeniX, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Posted 28 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: G-CSF | Active comparator | Biological: G-CSFIntervention: G-CSF given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Filgrastim |
| Comparator: Placebo/Saline | Placebo comparator | Other: Placebo/SalineIntervention: Placebo/saline given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Saline |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-CSFAlso: FilgrastimG-CSF injected subcutaneously 3 times (Days 0, 28, 56) | Biological | Experimental: G-CSF |
| Placebo/SalineAlso: SalinePlacebo/saline injected subcutaneously 3 times (Days 0, 28, 56) | Other | Comparator: Placebo/Saline |
Primary outcome
Number of Participants With Adverse Events
Time frame: 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.
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 12
Time frame: 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.
9 secondary outcomes
Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12
Time frame: Weeks 1-12
Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12
Time frame: Weeks 1-12
Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12
Time frame: Weeks 1-12
Percent Change in M+S at 12 Weeks in Demographic Subgroups
Time frame: Baseline and Week 12
Net Change in HFSS at 12 Weeks in Demographic Subgroups
Time frame: Baseline and Week 12
Net Change in MENQOL VMS Score
Time frame: Baseline and week 12
Net Change in HFRDIS Score
Time frame: Baseline and week 12
Net Change in ISI Score at 12 Weeks
Time frame: Baseline and week 12
Net Change in FSS Score at 12 Weeks
Time frame: Baseline and week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruitingPhase 4
Migraine Menopause Study
Migraine, Menopausal
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard C Duke, PhD study chair
MenoGeniX, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing G-CSF in people with Postmenopausal Symptoms, run by MenoGeniX, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: From first dose date up to 30 days after last dose (up to 16 weeks)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.