A Randomized, Double-Blind, Placebo-Controlled Phase 1b 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

Primary Objective

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 is
No Longer Enrolling

Details
Age

Adult

Type of Study

Treatment

Locations

Outpatient CTRC
University of Colorado Hospital

Study ID

Protocol Number: 18-1254

More information available at ClinicalTrials.gov: NCT03640754

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