Trials / Completed
CompletedNCT03596762
A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 199 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 40 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a multi-centre, multi-country, double-blind, randomised, placebo-controlled Phase 2b study. The study will have a single-blind run-in period and will be adaptive with respect to the number of subjects recruited into each dose group. Four doses of BAY3427080 (40 mg once a day, 80 mg once a day, 120 mg once a day and 160 mg once a day) will be investigated and compared to placebo, in five parallel groups. Subjects will participate in the study for a total of approximately 19 weeks, comprising a screening period of 1 week, a 14 week treatment period, and then a final follow up visit 4 weeks after the end of the treatment period. There will be a total of 8 visits whilst participating in the study. Subjects will record their hot flashes in an electronic diary during the screening period to establish eligibility and throughout the study after randomisation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elinzanetant (BAY3427080) | BAY3427080 capsules |
| DRUG | Placebo | Placebo capsules |
Timeline
- Start date
- 2018-11-20
- Primary completion
- 2019-11-21
- Completion
- 2019-11-21
- First posted
- 2018-07-24
- Last updated
- 2023-03-10
- Results posted
- 2023-03-10
Locations
25 sites across 3 countries: United States, Canada, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03596762. Inclusion in this directory is not an endorsement.