CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167, Germany
NCT Number: NCT04845841
Researchers are looking for a new way to treat women who have symptoms by hormonal changes, like those that happen in women during menopause. These symptoms can include hot flashes, night sweats, and changes in blood pressure. These symptoms are caused by hormonal changes occurring during menopausal transition when women may have also changes in their monthly cycles. The menopausal transition most often begins between ages 45 and 55 and leads to menopause, a point in time 12 months after a woman's last period.
The study drug, elinzanetant, was designed to treat symptoms caused by hormonal changes. Before a new treatment can be approved for people to take, researchers perform clinical trials to better understand how this treatment works and to investigate safety.
The purpose of this study is to assess the blood levels of elinzanetant when given as 2 capsules of dose A (what is intended for further research and future commercialization) and also to compare the blood levels when given as 3 capsules of dose B (what was used for research up to now). Furthermore, researchers want to find out if taking of elinzanetant on two time points leads to differences in blood levels of elinzanetant.
This trial will be performed in healthy women aged 40 to 65 years.
Looking for future studies?
Notify Me40 year–65 year
Female
Interventional
Phase 1
Mannheim, Baden-Wurttemberg, 68167, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single oral dose
Single oral dose
Time frame: Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit)
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose
Time frame: Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit)
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
Time frame: Approximately 2 to 3 months
Time frame: Approximately 2 to 3 months
Bayer
Industry
Single Center, Randomized, Open-label, Cross-over Study to Investigate the Pharmacokinetics of Two Oral Formulations of Elinzanetant After Single Dosing in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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