BridgeMD
A study to learn about how elinzanetant works and how safe it is in women having sleep disturbances associated with menopause
EU CTIS ID: 2023-504955-28-01
What this study is testing
To explore the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by PSG
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- 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
- Abnormal liver parameters (presence of at least one of the following criteria): - AST >2 x ULN - ALT >2 x ULN - AP >2 x ULN - TBL >ULN unless explained by Gilbert’s syndrome - INR >ULN unless explained by, e.g., intake of anticoagulants - Diagnosis of hepatitis B infection, i.e., Hbs-antigen positive at screening - Diagnosis of hepatitis C infection, i.e., hepatitis C-antibodies and HCV-RNA positive at screening.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.