Status:
COMPLETED
A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women
Lead Sponsor:
Bayer
Conditions:
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Hot Flashes
Eligibility:
FEMALE
40-65 years
Phase:
PHASE1
Brief Summary
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 ski...
Eligibility Criteria
Inclusion
- Females aged 40 to 65 years, inclusive, at signing of informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and electrocardiogram (ECG).
- Participant has a regular sleep pattern, is not engaged in shift-work, and in general, has at least 7 hours of sleep each night (bedtime occurs between 21:00 and 24:00 hours).
- Participant possesses a valid driver's license and is an active driver. Drives a minimum of 8,000 kilometers per year for the previous 3 years.
Exclusion
- Relevant diseases within the last 4 weeks prior to the first administration of study intervention, including febrile illness.
- A history within 2 years of, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the participant's sleep.
- Abnormal finding in the physical examination, ECG, blood pressure, pulse rate or clinical laboratory results at Screening, that are considered clinically significant by the investigator.
- Use of any medication of dietary supplement which may affect central nervous system (CNS) function and may confound the pharmacodynamic assessments of the study.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06219902
Start Date
January 8 2024
End Date
April 15 2024
Last Update
May 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AltaSciences
Mount Royal, Canada, H3P 3P1