Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206408
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-01-04
Brief Title:
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in 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 Assess the Efficacy and Safety of Fezolinetant in Japanese Women Experiencing 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 2
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
This study will confirm if fezolintant helps reduce the number of hot flashes in Japanese women going through menopause
Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes Some women may be able to use the app on their own smartphone Before the women are assigned a treatment they will record information about their hot flashes
Women will either take a lower or higher dose of 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 2 tablets of the study medicine lower or higher dose of fezolinetant or the placebo once a day for up to 12 weeks They will either take 1 tablet of fezolinetant higher or lower dose and 1 placebo tablet or they will take 2 placebo tablets The women will continue to record information about their hot flashes on the electronic device or their smartphone
During the study the women will visit the study clinic a few times At each visit they will be asked if they had any medical problems and will use an electronic device at the clinic to answer questions about how the hot flashes affect their daily life Other checks will include a medical examination vital signs temperature blood pressure and pulse Some blood and urine samples will be taken for laboratory tests At some visits the women will also have an ECG to check their heart rhythm 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 tablets of the study medicine 1 tablet of lower or higher dose of fezolinetant and 1 placebo tablet or 2 placebo tablets
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
This study will confirm if fezolintant helps reduce the number of hot flashes in Japanese women going through menopause
Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes Some women may be able to use the app on their own smartphone Before the women are assigned a treatment they will record information about their hot flashes
Women will either take a lower or higher dose of 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 2 tablets of the study medicine lower or higher dose of fezolinetant or the placebo once a day for up to 12 weeks They will either take 1 tablet of fezolinetant higher or lower dose and 1 placebo tablet or they will take 2 placebo tablets The women will continue to record information about their hot flashes on the electronic device or their smartphone
During the study the women will visit the study clinic a few times At each visit they will be asked if they had any medical problems and will use an electronic device at the clinic to answer questions about how the hot flashes affect their daily life Other checks will include a medical examination vital signs temperature blood pressure and pulse Some blood and urine samples will be taken for laboratory tests At some visits the women will also have an ECG to check their heart rhythm 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 tablets of the study medicine 1 tablet of lower or higher dose of fezolinetant and 1 placebo tablet or 2 placebo tablets
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 |
|---|---|---|---|
| jRCT2031230571 | REGISTRY | jRCT | None |