A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopa… (NCT03640754) | Clinical Trial Compass
CompletedPhase 1
A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women
United States61 participantsStarted 2018-08-06
Plain-language 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.
Who can participate
Age range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: From first dose date up to 30 days after last dose (up to 16 weeks)
2
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0
Timeframe: Baseline and day 1
3
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 28
Timeframe: Baseline and day 29
4
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 56.
Timeframe: Baseline and day 57
5
Change From Baseline in White Blood Cell Counts on Day 84 (28 Days After Last Administration of G-CSF or Palcebo)
Timeframe: Baseline and day 84
6
Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 4
Timeframe: Baseline and week 4
7
Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 12