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A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study for 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.

Study category: Women's Health

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Description

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.

Details
Age

40 to 65 years

Type of Study

Treatment

Compensation

1000

Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Nanette Santoro,  MD

Nanette Santoro, MD

Study ID

Protocol Number: 18-1254

More information available at ClinicalTrials.gov: NCT03640754

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