pause_circle_filledNot Yet Recruiting
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes
Bayer Identifier:
22653
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women
Trial purpose
Researchers are looking for a better way to treat vasomotor symptoms (VMS), also known as hot flashes.
Hot flashes are intense and sudden feelings of heat along with sweating and reddening of the skin. These are common for women going through the menopause but can also occur in men. Such symptoms are called VMS and are caused by changes in sex hormone levels.
The study treatment, elinzanetant, is being tested for the treatment of VMS in both men and women. It works by blocking the activity of a substance called neurokinin, which is thought to play a role in starting hot flashes.
Elinzanetant may cause lasting effects like sleepiness and tiredness. Such effects may make driving unsafe.
The main purpose of this study is to learn how elinzanetant affects the ability to drive the next day in healthy women.
For this, researchers will study participants’ ability to keep a stable position within their lane while driving on a straight road on a computer-based driving test (also known as a driving simulator).
In this study, participants will take 2 different doses of elinzanetant, another drug called zopiclone, and matching placebos to these drugs.
Zopiclone helps treat sleeping problems. A placebo looks like a study drug but does not have any medicine in it.
Participants will take elinzanetant, zopiclone, and their matching placebos by mouth.
This study will have 4 treatment periods with each period lasting 6 days. In each period, participants will receive one of the following treatments in an order assigned to them randomly (by chance):
- dose A of elinzanetant and a zopiclone placebo
- dose B of elinzanetant and a zopiclone placebo
- zopiclone 7.5 milligrams (mg) and elinzanetant placebo
- elinzanetant placebo and zopiclone placebo
Each participant will be in the study for around 15 weeks with up to 6 visits to the study site.
Participants will visit the study site:
- once before the treatment starts, so the study doctors and their team can check on their health and confirm if the participant can join the study
- once in each of the 4 treatment periods for a 6-day stay at the study site with a gap of 14 days between each period. During each stay, they will take the assigned treatment from Days 1 to 5 and the driving test on Days 2 and 6
- once, 7 to 21 days after their last treatment so the study doctors and their team can check on their health
During the study, the doctors and their study team will:
- check participants’ health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
- check the participants’ ability to drive and their brain function and level of sleepiness using different tests including a driving simulator test
- check the level of the study drugs in participants’ blood
- ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment or not.
Hot flashes are intense and sudden feelings of heat along with sweating and reddening of the skin. These are common for women going through the menopause but can also occur in men. Such symptoms are called VMS and are caused by changes in sex hormone levels.
The study treatment, elinzanetant, is being tested for the treatment of VMS in both men and women. It works by blocking the activity of a substance called neurokinin, which is thought to play a role in starting hot flashes.
Elinzanetant may cause lasting effects like sleepiness and tiredness. Such effects may make driving unsafe.
The main purpose of this study is to learn how elinzanetant affects the ability to drive the next day in healthy women.
For this, researchers will study participants’ ability to keep a stable position within their lane while driving on a straight road on a computer-based driving test (also known as a driving simulator).
In this study, participants will take 2 different doses of elinzanetant, another drug called zopiclone, and matching placebos to these drugs.
Zopiclone helps treat sleeping problems. A placebo looks like a study drug but does not have any medicine in it.
Participants will take elinzanetant, zopiclone, and their matching placebos by mouth.
This study will have 4 treatment periods with each period lasting 6 days. In each period, participants will receive one of the following treatments in an order assigned to them randomly (by chance):
- dose A of elinzanetant and a zopiclone placebo
- dose B of elinzanetant and a zopiclone placebo
- zopiclone 7.5 milligrams (mg) and elinzanetant placebo
- elinzanetant placebo and zopiclone placebo
Each participant will be in the study for around 15 weeks with up to 6 visits to the study site.
Participants will visit the study site:
- once before the treatment starts, so the study doctors and their team can check on their health and confirm if the participant can join the study
- once in each of the 4 treatment periods for a 6-day stay at the study site with a gap of 14 days between each period. During each stay, they will take the assigned treatment from Days 1 to 5 and the driving test on Days 2 and 6
- once, 7 to 21 days after their last treatment so the study doctors and their team can check on their health
During the study, the doctors and their study team will:
- check participants’ health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
- check the participants’ ability to drive and their brain function and level of sleepiness using different tests including a driving simulator test
- check the level of the study drugs in participants’ blood
- ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment or not.
Key Participants Requirements
Sex
FemaleAge
40 - 65 YearsTrial summary
Enrollment Goal
60Trial Dates
January 2024 - April 2024Phase
Phase 1Could I Receive a placebo
YesProducts
Elinzanetant (BAY3427080)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Not yet recruiting | AltaSciences | Mount-Royal, H3P 3P1, Canada |
Primary Outcome
- Simulated driving performance as measured by SDLP using CRCDS-MiniSimSDLP: standard deviation of lateral position. CRCDS-MiniSim: Cognitive Research Corporation's Driving Simulator-MiniSim.date_rangeTime Frame:Up to 7-21 days after the last dose
Secondary Outcome
- Lane Exceedance, including Number, Maximum Duration, and Area of Exceedance.date_rangeTime Frame:Up to 7-21 days after the last dose
- Excessive Speed Countdate_rangeTime Frame:Up to 7-21 days after the last dose
- Average Speed and Speed Deviationdate_rangeTime Frame:Up to 7-21 days after the last dose
- Excessive Ay (cornering speed threshold exceeded)date_rangeTime Frame:Up to 7-21 days after the last dose
- Total Collisionsdate_rangeTime Frame:Up to 7-21 days after the last dose
- Divided Attention: Correct responses; Omission Errors; Commission Errors; Reaction Time; Standard Deviation of Reaction Timedate_rangeTime Frame:Up to 7-21 days after the last dose
- Number of Correct responsesdate_rangeTime Frame:Up to 7-21 days after the last dose
- Response Accuracydate_rangeTime Frame:Up to 7-21 days after the last dose
- Standard Deviation of Reaction Timedate_rangeTime Frame:Up to 7-21 days after the last dose
- Karolinska Sleepiness Scale (KSS) Scoredate_rangeTime Frame:Up to 7-21 days after the last dose
- Participant’s self-reported Readiness to Drivedate_rangeTime Frame:Up to 7-21 days after the last dose
- Self-report of motivation and appraisal of driving performance using VASdate_rangeTime Frame:Up to 7-21 days after the last dose
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
4