At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 199 enrolled
Drug / intervention
Elinzanetant (BAY3427080) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomised, Placebo Controlled, Adaptive Design Study of the Efficacy, Safety and Pharmacokinetics of NT-814 in Female Subjects With Moderate to Severe Vasomotor Symptoms Associated With the Menopause
In Brief
A Phase 2 clinical trial evaluating Elinzanetant (BAY3427080) and Placebo for Menopause and 2 related conditions. Completed, enrolled 199 participants across 25 sites in 3 countries.
Detailed Summary
The purpose of this study is to determine the effectiveness of BAY3427080 (NT-814), taken once a day, in the treatment of troublesome post-menopausal symptoms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause, Hot Flashes, Night Waking
CountriesCanada, United Kingdom, United States
CollaboratorsNerre Therapeutics Ltd.
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartNov 2018
Primary CompletionNov 2019
TodayJul 2026
First PostedJul 24, 2018
Enrollment StartNov 20, 2018
Primary CompletionNov 21, 2019
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.9 years ago
Interventions
Elinzanetant (BAY3427080)drug
BAY3427080 capsules
Placebodrug
Placebo capsules