The primary objective of this Phase 1b study is to assess the safety and pharmacodynamic (PD) effect of repeated subcutaneous injection of GCSF in healthy menopausal women. The secondary objective of this proposed study is to assess the efficacy of repeated administration of G-CSF in reducing the frequency and severity of hot flashes in postmenopausal women. The tertiary objective is to assess additional measures of hot flash burden.
This study will look at the effect of Filgrastim on women who are menopausal and are experiencing hot flashes.
We expect a reduction in the number of hot flashes the participants experience if they receive the study medication.
Main Procedures Involved: The main study procedures are physical, routine blood testing and study medication injection
Duration of Participation: There are a total of 10 study visits over 12 weeks. Compensation is up to $1000.
40 to 65 years
University of Colorado Hospital
Nanette Santoro, MD
Protocol Number: 18-1254
More information available at ClinicalTrials.gov: NCT03640754
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