Status:
COMPLETED
A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
Lead Sponsor:
Bayer
Conditions:
Sleep Disturbances Associated With Menopause
Eligibility:
FEMALE
40-65 years
Phase:
PHASE2
Brief Summary
Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause. Menopause is part of a natural aging process and happens when women's menstrual cycles, ...
Eligibility Criteria
Inclusion
- Females aged 40 to 65 years, inclusive, at signing of informed consent.
- Being in the post-menopausal period, defined as: serum FSH levels \>40 mIU/mL and a serum estradiol concentration of \<30 pg/mL at screening, AND Hysterectomy performed at least 6 weeks prior to screening.
- The participant's self-reported sleep history includes ongoing sleep disturbances associated with menopause characterized by waking up at night and/or poor quality of sleep.
- WASO of 30 minutes or more (mean of 2 screening PSGs with neither of the 2 nights \<20 min).
Exclusion
- Medical history, or baseline PSG assessment, includes a diagnosis of a sleep disorder other than sleep disturbances associated with the menopause (e.g., sleep apnea, restless leg syndrome, circadian rhythm sleep disorder).
- Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors).
- Renal impairment greater than moderate (i.e. estimated glomerular filtration rate \<30 mL/min/1.73 m\^2) at screening
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2024
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06112756
Start Date
November 8 2023
End Date
November 7 2024
Last Update
November 10 2025
Active Locations (40)
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1
Preferred Research Partners
Little Port Walter, Alaska, United States, 72211
2
MomDoc Women's Health Research | Scottsdale, AZ
Scottsdale, Arizona, United States, 85251
3
Diagnamics | Encinitas, CA
Encinitas, California, United States, 92024
4
SDS Clinical Trials Inc
Santa Ana, California, United States, 92705