A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03640754|
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : October 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Postmenopausal Symptoms||Biological: G-CSF Other: Placebo/Saline||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Experimental: G-CSF
Intervention: G-CSF given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Filgrastim
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
Placebo/saline injected subcutaneously 3 times (Days 0, 28, 56)
Other Name: Saline
- Safety as assessed by the number of adverse events following repeated subcutaneous injection of G-CSF [ Time Frame: Baseline to Weeks 12 ]
- Circulating white blood cells concentrations as measured by change from baseline. [ Time Frame: Baseline to Week 12 ]
- Circulating hormone concentrations as measured by change from baseline. [ Time Frame: Baseline to Week 12 ]
- Circulating inflammatory cytokine concentrations as measured by change from baseline. [ Time Frame: Baseline to Week 12 ]
- 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 ]
- 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 ]
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
|Contact: Cynthia Schechterfirstname.lastname@example.org|
|Contact: Debra Dukeemail@example.com|
|United States, Colorado|
|Site 2||Not yet recruiting|
|Aurora, Colorado, United States, 80045|
|Denver, Colorado, United States, 80209|
|Study Chair:||Richard C Duke, PhD||MenoGeniX, Inc.|