CompletedPhase 1

A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women

United States61 participantsStarted 2018-08-06

Plain-language 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.

Who can participate

Age range40 Years – 65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female, aged 49 to 65 for natural postmenopausal or aged 40 to 65 for surgical postmenopausal * Body Mass Index (BMI) 18 to 35 * At least 7 moderate to severe hot flashes per day on average (or at least 49 moderate to severe hot flashes per week) * Naturally postmenopausal or surgically postmenopausal women: * Naturally postmenopausal is defined as having no menstrual periods for at least 12 months prior to study entry; with a biochemical criteria of menopause (FSH \>40 IU/L) * Surgically postmenopausal is defined as at least 3 months after documented bilateral salpingo oophorectomy * Normal pelvic exam and pap smear within 2 years * Signed informed consent Exclusion Criteria: * Radiation or chemotherapy-induced (including gonadotropin-releasing hormone (GnRH) agonist) menopause * Prior chemotherapy or radiation therapy for cancer * Prior diagnosis of hematologic malignancy * Type 1 diabetics or Type 2 diabetics with HbA1c \> 7.0% * Use of hormone replacement therapy or oral contraceptives within the past three months * Use of alternative or complementary medicines or herbs for menopausal symptoms within 30 days (refer to Appendix 2) * Use of any selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) within 30 days * Use of selective estrogen receptor modulators within 30 days * Use of gabapentin within 30 days * Use of clonidine within 30 days * Use of megestrol acetate (Megace) within 30 days * Use of, pr…

What they're measuring

Number of Participants With Adverse Events

Timeframe: From first dose date up to 30 days after last dose (up to 16 weeks)

Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0

Timeframe: Baseline and day 1

Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 28

Timeframe: Baseline and day 29

Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 56.

Timeframe: Baseline and day 57

Change From Baseline in White Blood Cell Counts on Day 84 (28 Days After Last Administration of G-CSF or Palcebo)

Timeframe: Baseline and day 84

Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 4

Timeframe: Baseline and week 4

Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 12

Timeframe: Baseline and week 12

Trial details

NCT IDNCT03640754

SponsorMenoGeniX, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-21

Results submitted2023-05-31

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