CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 61 enrolled
Drug / intervention
G-CSF +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03640754
NCT03640754Phase 1Completed
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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

MenoGeniX, Inc.·interventional·Posted Aug 21, 2018·Updated Nov 28, 2023

In Brief

A Phase 1 clinical trial evaluating G-CSF and Placebo/Saline for Postmenopausal Symptoms. Completed, enrolled 61 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Symptoms
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute on Aging (NIA)

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedAug 21, 2018
Enrollment StartAug 6, 2018
Primary CompletionJan 21, 2022
Study CompletionFeb 22, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.9 years ago

Interventions

G-CSFbiological

G-CSF injected subcutaneously 3 times (Days 0, 28, 56)

Placebo/Salineother

Placebo/saline injected subcutaneously 3 times (Days 0, 28, 56)