Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206421
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-01-04
Brief Title:
A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 3 Randomized Placebo-controlled Double-blind Study to Investigate the Long Term Safety of Fezolinetant in Japanese Women Suffering From Vasomotor Symptoms Hot Flashes Associated With Menopause
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Starlight 3
Brief Summary:
Hot flashes are the most common reason women going through menopause seek medical attention Hormone replacement therapy or HRT is most often prescribed to treat hot flashes However HRT cant be used by all women or for as long as may be needed
Researchers want to find other ways to treat hot flashes Fezolinetant is a medicine to treat hot flashes in women going through menopause Fezolinetant is an approved medicine in the US Further studies are needed before it is available in other regions such as Asia
In this study fezolinetant will be used to treat hot flashes in Japanese women going through menopause This study will confirm the safety of fezolinetant and how well the women tolerate the treatment
Women will either take fezolinetant or a placebo This is decided by chance alone The placebo looks like fezolinetant but will not have any medicine in it
The women will take 1 tablet of the study medicine fezolinetant or the placebo once a day for up to 52 weeks
During the study the women will visit their study clinic for a check-up about every 4 weeks for up to 52 weeks 1 year At each visit they will be asked if they had any medical problems Other checks will include a medical examination and vital signs temperature blood pressure and pulse At some visits the women will have an ECG to check their heart rhythm and some blood and urine samples will be taken for laboratory tests During a couple of visits women who have a womb uterus will also have a test called a transvaginal ultrasound A probe is gently placed inside the vagina Sound waves will create a picture of the organs in the pelvis This will allow the study doctor to look more closely at the uterus and surrounding organs
The last clinic visit will be 3 weeks after the women take their final tablet of the study medicine fezolinetant or the placebo
Researchers want to find other ways to treat hot flashes Fezolinetant is a medicine to treat hot flashes in women going through menopause Fezolinetant is an approved medicine in the US Further studies are needed before it is available in other regions such as Asia
In this study fezolinetant will be used to treat hot flashes in Japanese women going through menopause This study will confirm the safety of fezolinetant and how well the women tolerate the treatment
Women will either take fezolinetant or a placebo This is decided by chance alone The placebo looks like fezolinetant but will not have any medicine in it
The women will take 1 tablet of the study medicine fezolinetant or the placebo once a day for up to 52 weeks
During the study the women will visit their study clinic for a check-up about every 4 weeks for up to 52 weeks 1 year At each visit they will be asked if they had any medical problems Other checks will include a medical examination and vital signs temperature blood pressure and pulse At some visits the women will have an ECG to check their heart rhythm and some blood and urine samples will be taken for laboratory tests During a couple of visits women who have a womb uterus will also have a test called a transvaginal ultrasound A probe is gently placed inside the vagina Sound waves will create a picture of the organs in the pelvis This will allow the study doctor to look more closely at the uterus and surrounding organs
The last clinic visit will be 3 weeks after the women take their final tablet of the study medicine fezolinetant or the placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| jRCT2031230584 | REGISTRY | jRCT | None |