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Treatment sequences C-B-A-D for Hot Flashes

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females aged 40 to 65 years, inclusive, at signing of informed consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 9 hours after last dose
Awards & highlights

Study Summary

This trial is testing a new treatment called elinzanetant for hot flashes, which are intense feelings of heat, sweating, and redness of the skin. The treatment works by blocking a substance

Who is the study for?
This trial is for healthy women experiencing vasomotor symptoms like hot flashes due to hormone imbalance. Participants should be able to complete a driving simulator test and commit to multiple study site visits over approximately 15 weeks.Check my eligibility
What is being tested?
The trial tests elinzanetant's effect on driving ability and brain function in women with hot flashes. It involves comparing two doses of elinzanetant, a sleep aid drug zopiclone, and placebos through four treatment periods using a computer-based driving simulation.See study design
What are the potential side effects?
Elinzanetant may cause drowsiness or tiredness that could affect activities such as driving. Zopiclone is known for treating sleep issues but can also lead to similar side effects like sleepiness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged between 40 and 65.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 9 hours after last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 9 hours after last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Simulated driving performance as measured by SDLP using CRCDS-MiniSim
Secondary outcome measures
Average Speed and Speed Deviation
CogScreen Symbol Digit Coding Test: Number of Correct responses
CogScreen Symbol Digit Coding Test: Response Accuracy (percentage of correct responses)
+11 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Treatment sequences D-A-B-CExperimental Treatment4 Interventions
Treatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo).).
Group II: Treatment sequences C-B-A-DExperimental Treatment4 Interventions
Treatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo).
Group III: Treatment sequences B-D-C-AExperimental Treatment4 Interventions
Treatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo).
Group IV: Treatment sequences A-C-D-BExperimental Treatment4 Interventions
Treatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elinzanetant (BAY3427080)
2022
Completed Phase 3
~1870
Zopiclone
2011
Completed Phase 4
~1850

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BayerLead Sponsor
2,237 Previous Clinical Trials
25,326,914 Total Patients Enrolled
13 Trials studying Hot Flashes
3,540 Patients Enrolled for Hot Flashes

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which specific group of individuals is the most suitable to participate in this study?

"For potential inclusion in this clinical trial, patients should experience hot flashes and fall within the age range of 40 to 65 years. The study is currently accepting approximately 60 eligible participants."

Answered by AI

Is the recruitment phase for this medical study currently ongoing?

"According to the latest information on clinicaltrials.gov, this trial is presently accepting participants. The initial posting was made on January 8th, 2024, and the most recent update occurred on January 12th, 2024."

Answered by AI

What is the current number of individuals under observation in this medical research study?

"Indeed, as per the information provided on clinicaltrials.gov, this trial is presently in the process of recruiting eligible individuals. The initial posting date for this study was January 8th, 2024 and it was last updated on January 12th, 2024. A total of 60 participants are being sought from a single designated site."

Answered by AI

What is the level of safety associated with the treatment sequence A-C-D-B for individuals?

"Based on the classification of this trial as a Phase 1 study, our team assigns a safety rating of 1 to the treatment sequences A-C-D-B. This indicates that there is limited data available regarding both safety and efficacy."

Answered by AI

Is the age criterion for participant inclusion in this study limited to individuals above 60 years old?

"Subjects who meet the age criteria for this trial must be above 40 years old and below 65 years of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women
2024. "A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06219902.
~43 spots leftby Apr 2025
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