NCT03596762 (SWITCH-1) is a Phase 2 clinical trial of Elinzanetant (BAY3427080) in Menopause, sponsored by Bayer.

Who is sponsoring NCT03596762?

NCT03596762 is sponsored by Bayer.

What drugs are being tested in NCT03596762?

Interventions in NCT03596762: Elinzanetant (BAY3427080), Placebo.

What condition does NCT03596762 study?

NCT03596762 studies Menopause, Hot Flashes, Night Waking.

Is NCT03596762 still recruiting?

NCT03596762 is currently completed. Last updated 10 March 2023.

Are results published for NCT03596762?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-10 · How we verify

NCT03596762: SWITCH-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms

Completed Phase 2 Results posted Last updated 10 March 2023

What this trial tests

Phase 2 trial testing Elinzanetant (BAY3427080) in Menopause in 199 participants. Completed in 21 November 2019.

Timeline

20 November 2018

Primary endpoint
21 November 2019

21 November 2019

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	199
Start date	20 November 2018
Primary completion	21 November 2019
Estimated completion	21 November 2019
Sites	25 locations across United Kingdom, Canada, United States

Drugs / interventions tested

Elinzanetant (BAY3427080) — full drug profile →
Placebo

Conditions studied

Menopause — all drugs for Menopause →
Hot Flashes — all drugs for Hot Flashes →
Night Waking — all drugs for Night Waking →

Sponsor

Bayer — full company profile →

Who can join

Adults 40 to 65, female only, with Menopause or Hot Flashes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 Primary · From baseline to Week 4

Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in

Baseline

Group	Value	95% CI
Placebo	11.82	± 4.42
40 mg Elinzanetant (BAY3427080)	12.13	± 8.81
80 mg Elinzanetant (BAY3427080)	14.55	± 5.87
120 mg Elinzanetant (BAY3427080)	13.54	± 7.17
160 mg Elinzanetant (BAY3427080)	12.92	± 6.90

Week 4: Change from baseline

Group	Value	95% CI
Placebo	-2.45	± 3.65
40 mg Elinzanetant (BAY3427080)	-4.19	± 5.78
80 mg Elinzanetant (BAY3427080)	-4.30	± 6.45
120 mg Elinzanetant (BAY3427080)	-6.76	± 5.85
160 mg Elinzanetant (BAY3427080)	-5.42	± 5.36

Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 Primary · From baseline to Week 12

Baseline

Group	Value	95% CI
Placebo	11.82	± 4.42
40 mg Elinzanetant (BAY3427080)	12.13	± 8.81
80 mg Elinzanetant (BAY3427080)	14.55	± 5.87
120 mg Elinzanetant (BAY3427080)	13.54	± 7.17
160 mg Elinzanetant (BAY3427080)	12.92	± 6.90

Week 12: Change from baseline

Group	Value	95% CI
Placebo	-4.49	± 4.29
40 mg Elinzanetant (BAY3427080)	-6.48	± 7.82
80 mg Elinzanetant (BAY3427080)	-5.49	± 5.31
120 mg Elinzanetant (BAY3427080)	-7.91	± 6.66
160 mg Elinzanetant (BAY3427080)	-6.57	± 5.83

Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 Primary · From baseline to Week 4

Participants recorded daily in their eDiary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).

Baseline

Group	Value	95% CI
Placebo	2.54	± 0.20
40 mg Elinzanetant (BAY3427080)	2.51	± 0.26
80 mg Elinzanetant (BAY3427080)	2.63	± 0.24
120 mg Elinzanetant (BAY3427080)	2.54	± 0.24
160 mg Elinzanetant (BAY3427080)	2.54	± 0.26

Week 4: Change from baseline

Group	Value	95% CI
Placebo	-0.31	± 0.41
40 mg Elinzanetant (BAY3427080)	-0.38	± 0.54
80 mg Elinzanetant (BAY3427080)	-0.44	± 0.56
120 mg Elinzanetant (BAY3427080)	-0.51	± 0.57
160 mg Elinzanetant (BAY3427080)	-0.54	± 0.67

Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 Primary · From baseline to Week 12

Participants recorded daily in their eDiary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity was graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).

Baseline

Group	Value	95% CI
Placebo	2.54	± 0.20
40 mg Elinzanetant (BAY3427080)	2.51	± 0.26
80 mg Elinzanetant (BAY3427080)	2.63	± 0.24
120 mg Elinzanetant (BAY3427080)	2.54	± 0.24
160 mg Elinzanetant (BAY3427080)	2.54	± 0.26

Week 12: Change from baseline

Group	Value	95% CI
Placebo	-0.41	± 0.50
40 mg Elinzanetant (BAY3427080)	-0.53	± 0.64
80 mg Elinzanetant (BAY3427080)	-0.26	± 0.45
120 mg Elinzanetant (BAY3427080)	-0.56	± 0.68
160 mg Elinzanetant (BAY3427080)	-0.73	± 0.78

Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 Secondary · From baseline to Weeks 1, 2, 8 and 16

Baseline

Group	Value	95% CI
Placebo	11.82	± 4.42
40 mg Elinzanetant (BAY3427080)	12.13	± 8.81
80 mg Elinzanetant (BAY3427080)	14.55	± 5.87
120 mg Elinzanetant (BAY3427080)	13.54	± 7.17
160 mg Elinzanetant (BAY3427080)	12.92	± 6.90

Week 1: Change from baseline

Group	Value	95% CI
Placebo	-1.22	± 3.07
40 mg Elinzanetant (BAY3427080)	-1.61	± 3.05
80 mg Elinzanetant (BAY3427080)	-1.63	± 3.56
120 mg Elinzanetant (BAY3427080)	-3.22	± 3.43
160 mg Elinzanetant (BAY3427080)	-3.09	± 3.76

Week 2: Change from baseline

Group	Value	95% CI
Placebo	-2.19	± 4.01
40 mg Elinzanetant (BAY3427080)	-3.03	± 3.95
80 mg Elinzanetant (BAY3427080)	-3.47	± 4.37
120 mg Elinzanetant (BAY3427080)	-4.58	± 4.70
160 mg Elinzanetant (BAY3427080)	-3.78	± 4.48

Week 8: Change from baseline

Group	Value	95% CI
Placebo	-4.33	± 4.79
40 mg Elinzanetant (BAY3427080)	-5.72	± 6.18
80 mg Elinzanetant (BAY3427080)	-5.94	± 5.26
120 mg Elinzanetant (BAY3427080)	-7.84	± 5.95
160 mg Elinzanetant (BAY3427080)	-5.58	± 6.00

Week 16: Change from baseline

Group	Value	95% CI
Placebo	-3.95	± 4.85
40 mg Elinzanetant (BAY3427080)	-5.74	± 9.45
80 mg Elinzanetant (BAY3427080)	-2.01	± 4.99
120 mg Elinzanetant (BAY3427080)	-5.95	± 6.95
160 mg Elinzanetant (BAY3427080)	-2.78	± 6.54

Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 Secondary · From baseline to Weeks 1, 2, 8 and 16

Participants recorded daily in their diary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).

Baseline

Group	Value	95% CI
Placebo	2.54	± 0.20
40 mg Elinzanetant (BAY3427080)	2.51	± 0.26
80 mg Elinzanetant (BAY3427080)	2.63	± 0.24
120 mg Elinzanetant (BAY3427080)	2.54	± 0.24
160 mg Elinzanetant (BAY3427080)	2.55	± 0.26

Week 1: Change from baseline

Group	Value	95% CI
Placebo	-0.24	± 0.30
40 mg Elinzanetant (BAY3427080)	-0.21	± 0.20
80 mg Elinzanetant (BAY3427080)	-0.22	± 0.21
120 mg Elinzanetant (BAY3427080)	-0.25	± 0.28
160 mg Elinzanetant (BAY3427080)	-0.26	± 0.26

Week 2: Change from baseline

Group	Value	95% CI
Placebo	-0.30	± 0.39
40 mg Elinzanetant (BAY3427080)	-0.32	± 0.32
80 mg Elinzanetant (BAY3427080)	-0.42	± 0.58
120 mg Elinzanetant (BAY3427080)	-0.37	± 0.46
160 mg Elinzanetant (BAY3427080)	-0.40	± 0.55

Week 8: Change from baseline

Group	Value	95% CI
Placebo	-0.45	± 0.58
40 mg Elinzanetant (BAY3427080)	-0.48	± 0.54
80 mg Elinzanetant (BAY3427080)	-0.40	± 0.61
120 mg Elinzanetant (BAY3427080)	-0.51	± 0.54
160 mg Elinzanetant (BAY3427080)	-0.65	± 0.73

Week 16: Change from baseline

Group	Value	95% CI
Placebo	2.15	± 0.65
40 mg Elinzanetant (BAY3427080)	2.03	± 0.56
80 mg Elinzanetant (BAY3427080)	2.50	± 0.46
120 mg Elinzanetant (BAY3427080)	2.13	± 0.71
160 mg Elinzanetant (BAY3427080)	2.08	± 0.62

Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Secondary · From baseline to Weeks 1, 2, 4, 8, 12 and 16

Baseline

Group	Value	95% CI
Placebo	14.04	± 5.57
40 mg Elinzanetant (BAY3427080)	14.19	± 11.01
80 mg Elinzanetant (BAY3427080)	16.55	± 6.89
120 mg Elinzanetant (BAY3427080)	15.39	± 7.91
160 mg Elinzanetant (BAY3427080)	15.78	± 9.62

Week 1

Group	Value	95% CI
Placebo	-1.36	± 3.03
40 mg Elinzanetant (BAY3427080)	-1.72	± 3.27
80 mg Elinzanetant (BAY3427080)	-1.33	± 5.68
120 mg Elinzanetant (BAY3427080)	-3.30	± 3.99
160 mg Elinzanetant (BAY3427080)	-3.69	± 4.81

Week 2

Group	Value	95% CI
Placebo	-2.35	± 4.60
40 mg Elinzanetant (BAY3427080)	-2.99	± 4.90
80 mg Elinzanetant (BAY3427080)	-2.74	± 5.97
120 mg Elinzanetant (BAY3427080)	-4.57	± 5.48
160 mg Elinzanetant (BAY3427080)	-4.43	± 5.68

Week 4

Group	Value	95% CI
Placebo	-2.67	± 4.09
40 mg Elinzanetant (BAY3427080)	-4.11	± 6.31
80 mg Elinzanetant (BAY3427080)	-3.45	± 8.54
120 mg Elinzanetant (BAY3427080)	-6.70	± 6.16
160 mg Elinzanetant (BAY3427080)	-5.79	± 6.09

Week 8

Group	Value	95% CI
Placebo	-4.74	± 5.57
40 mg Elinzanetant (BAY3427080)	-5.65	± 6.55
80 mg Elinzanetant (BAY3427080)	-5.45	± 6.56
120 mg Elinzanetant (BAY3427080)	-7.96	± 6.16
160 mg Elinzanetant (BAY3427080)	-6.03	± 6.43

Week 12

Group	Value	95% CI
Placebo	-5.07	± 5.48
40 mg Elinzanetant (BAY3427080)	-6.50	± 8.67
80 mg Elinzanetant (BAY3427080)	-5.11	± 8.41
120 mg Elinzanetant (BAY3427080)	-7.94	± 6.74
160 mg Elinzanetant (BAY3427080)	-7.47	± 7.13

Week 16

Group	Value	95% CI
Placebo	-4.60	± 6.17
40 mg Elinzanetant (BAY3427080)	-5.83	± 10.86
80 mg Elinzanetant (BAY3427080)	-1.76	± 7.50
120 mg Elinzanetant (BAY3427080)	-6.19	± 7.68
160 mg Elinzanetant (BAY3427080)	-3.11	± 6.71

Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Secondary · From baseline to Weeks 1, 2, 4, 8, 12 and 16

Baseline

Group	Value	95% CI
Placebo	2.34	± 0.32
40 mg Elinzanetant (BAY3427080)	2.34	± 0.35
80 mg Elinzanetant (BAY3427080)	2.46	± 0.37
120 mg Elinzanetant (BAY3427080)	2.38	± 0.34
160 mg Elinzanetant (BAY3427080)	2.35	± 0.39

Week 1: Change from baseline

Group	Value	95% CI
Placebo	-0.04	± 0.23
40 mg Elinzanetant (BAY3427080)	-0.04	± 0.18
80 mg Elinzanetant (BAY3427080)	-0.05	± 0.12
120 mg Elinzanetant (BAY3427080)	-0.09	± 0.25
160 mg Elinzanetant (BAY3427080)	-0.07	± 0.18

Week 2: Change from baseline

Group	Value	95% CI
Placebo	-0.10	± 0.32
40 mg Elinzanetant (BAY3427080)	-0.15	± 0.27
80 mg Elinzanetant (BAY3427080)	-0.25	± 0.52
120 mg Elinzanetant (BAY3427080)	-0.21	± 0.46
160 mg Elinzanetant (BAY3427080)	-0.20	± 0.50

Week 4: Change from baseline

Group	Value	95% CI
Placebo	-0.11	± 0.36
40 mg Elinzanetant (BAY3427080)	-0.21	± 0.47
80 mg Elinzanetant (BAY3427080)	-0.27	± 0.49
120 mg Elinzanetant (BAY3427080)	-0.35	± 0.60
160 mg Elinzanetant (BAY3427080)	-0.34	± 0.63

Week 8: Change from baseline

Group	Value	95% CI
Placebo	-0.25	± 0.54
40 mg Elinzanetant (BAY3427080)	-0.31	± 0.47
80 mg Elinzanetant (BAY3427080)	-0.23	± 0.52
120 mg Elinzanetant (BAY3427080)	-0.35	± 0.55
160 mg Elinzanetant (BAY3427080)	-0.44	± 0.72

Week 12: Change from baseline

Group	Value	95% CI
Placebo	-0.21	± 0.44
40 mg Elinzanetant (BAY3427080)	-0.35	± 0.57
80 mg Elinzanetant (BAY3427080)	-0.08	± 0.41
120 mg Elinzanetant (BAY3427080)	-0.41	± 0.62
160 mg Elinzanetant (BAY3427080)	-0.52	± 0.79

Week 16: Change from baseline

Group	Value	95% CI
Placebo	-0.21	± 0.49
40 mg Elinzanetant (BAY3427080)	-0.30	± 0.52
80 mg Elinzanetant (BAY3427080)	0.05	± 0.34
120 mg Elinzanetant (BAY3427080)	-0.26	± 0.56
160 mg Elinzanetant (BAY3427080)	-0.24	± 0.54

Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 Secondary · From baseline to Weeks 1, 2, 4, 8, 12 and 16

Mean daily Hot Flushes score = Sum of (frequency x severity) filled in the diary during the last 7 days (with at least one available data in the evening and/or morning) divided by 7. Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).

Baseline

Group	Value	95% CI
Placebo	32.35	± 12.24
40 mg Elinzanetant (BAY3427080)	32.84	± 24.82
80 mg Elinzanetant (BAY3427080)	40.76	± 17.08
120 mg Elinzanetant (BAY3427080)	36.59	± 19.88
160 mg Elinzanetant (BAY3427080)	35.73	± 19.75

Week 1: Change from baseline

Group	Value	95% CI
Placebo	-3.09	± 8.16
40 mg Elinzanetant (BAY3427080)	-4.26	± 7.93
80 mg Elinzanetant (BAY3427080)	-4.18	± 11.27
120 mg Elinzanetant (BAY3427080)	-8.44	± 8.98
160 mg Elinzanetant (BAY3427080)	-8.67	± 10.53

Week 2: Change from baseline

Group	Value	95% CI
Placebo	-5.62	± 11.00
40 mg Elinzanetant (BAY3427080)	-7.88	± 10.77
80 mg Elinzanetant (BAY3427080)	-9.08	± 13.09
120 mg Elinzanetant (BAY3427080)	-11.98	± 12.39
160 mg Elinzanetant (BAY3427080)	-10.51	± 12.47

Week 4: Change from baseline

Group	Value	95% CI
Placebo	-6.62	± 9.79
40 mg Elinzanetant (BAY3427080)	-10.68	± 15.26
80 mg Elinzanetant (BAY3427080)	-11.39	± 18.82
120 mg Elinzanetant (BAY3427080)	-17.54	± 15.50
160 mg Elinzanetant (BAY3427080)	-14.20	± 14.30

Week 8: Change from baseline

Group	Value	95% CI
Placebo	-11.63	± 12.51
40 mg Elinzanetant (BAY3427080)	-14.64	± 16.33
80 mg Elinzanetant (BAY3427080)	-16.17	± 15.32
120 mg Elinzanetant (BAY3427080)	-20.54	± 15.80
160 mg Elinzanetant (BAY3427080)	-14.89	± 15.36

Week 12: Change from baseline

Group	Value	95% CI
Placebo	-12.33	± 11.96
40 mg Elinzanetant (BAY3427080)	-16.71	± 20.60
80 mg Elinzanetant (BAY3427080)	-14.93	± 16.83
120 mg Elinzanetant (BAY3427080)	-20.72	± 17.81
160 mg Elinzanetant (BAY3427080)	-17.70	± 15.38

Week 16: Change from baseline

Group	Value	95% CI
Placebo	-10.89	± 13.45
40 mg Elinzanetant (BAY3427080)	-14.93	± 25.48
80 mg Elinzanetant (BAY3427080)	-4.97	± 14.35
120 mg Elinzanetant (BAY3427080)	-15.60	± 19.03
160 mg Elinzanetant (BAY3427080)	-7.50	± 16.55

Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 Secondary · Week 12

The percent change from baseline at a visit Week 12 was calculated. Percent change = (change from baseline in mean daily frequency of moderate and severe hot flushes from baseline to Week 12 / Mean daily frequency of moderate and severe hot flushes at baseline) \* 100. A participant was considered as a responder with a reduction of ≥50% (or ≥80%) if the percent change was ≤-50 (or ≤-80).

>= 50% reduction

Group	Value	95% CI
Placebo	17
40 mg Elinzanetant (BAY3427080)	20
80 mg Elinzanetant (BAY3427080)	5
120 mg Elinzanetant (BAY3427080)	32
160 mg Elinzanetant (BAY3427080)	30
Placebo	27
40 mg Elinzanetant (BAY3427080)	10
80 mg Elinzanetant (BAY3427080)	11
120 mg Elinzanetant (BAY3427080)	19
160 mg Elinzanetant (BAY3427080)	13

>=80% reduction

Group	Value	95% CI
Placebo	8
40 mg Elinzanetant (BAY3427080)	6
80 mg Elinzanetant (BAY3427080)	0
120 mg Elinzanetant (BAY3427080)	16
160 mg Elinzanetant (BAY3427080)	18
Placebo	36
40 mg Elinzanetant (BAY3427080)	24
80 mg Elinzanetant (BAY3427080)	16
120 mg Elinzanetant (BAY3427080)	35
160 mg Elinzanetant (BAY3427080)	25

Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 Secondary · From baseline to Weeks 1, 2, 4, 8, 12 and 16

Participants were provided with an eDiary to document the number of night-time awakenings (NTA). Each evening, participants recorded the total number of hot flushes of each severity experienced that day since waking. Each morning upon waking, subjects recorded the number of times they woke up in the night and the total number of hot flushes of each severity experienced during the night.

Baseline

Group	Value	95% CI
Placebo	3.86	± 2.06
40 mg Elinzanetant (BAY3427080)	3.44	± 1.82
80 mg Elinzanetant (BAY3427080)	5.00	± 1.76
120 mg Elinzanetant (BAY3427080)	3.80	± 2.20
160 mg Elinzanetant (BAY3427080)	3.85	± 2.57

Week 1: Change from baseline

Group	Value	95% CI
Placebo	-0.65	± 1.08
40 mg Elinzanetant (BAY3427080)	-0.70	± 1.24
80 mg Elinzanetant (BAY3427080)	-0.57	± 1.57
120 mg Elinzanetant (BAY3427080)	-0.91	± 1.06
160 mg Elinzanetant (BAY3427080)	-0.86	± 1.93

Week 2: Change from baseline

Group	Value	95% CI
Placebo	-0.62	± 1.54
40 mg Elinzanetant (BAY3427080)	-0.70	± 1.20
80 mg Elinzanetant (BAY3427080)	-1.09	± 1.84
120 mg Elinzanetant (BAY3427080)	-1.10	± 1.34
160 mg Elinzanetant (BAY3427080)	-1.00	± 2.10

Week 4: Change from baseline

Group	Value	95% CI
Placebo	-0.86	± 1.40
40 mg Elinzanetant (BAY3427080)	-1.05	± 1.43
80 mg Elinzanetant (BAY3427080)	-0.99	± 2.96
120 mg Elinzanetant (BAY3427080)	-1.49	± 1.43
160 mg Elinzanetant (BAY3427080)	-1.03	± 2.22

Week 8: Change from baseline

Group	Value	95% CI
Placebo	-0.99	± 1.31
40 mg Elinzanetant (BAY3427080)	-1.66	± 1.77
80 mg Elinzanetant (BAY3427080)	-1.30	± 2.15
120 mg Elinzanetant (BAY3427080)	-1.79	± 1.47
160 mg Elinzanetant (BAY3427080)	-1.17	± 2.51

Week 12: Change from baseline

Group	Value	95% CI
Placebo	-1.28	± 1.44
40 mg Elinzanetant (BAY3427080)	-1.53	± 1.89
80 mg Elinzanetant (BAY3427080)	-1.61	± 2.46
120 mg Elinzanetant (BAY3427080)	-1.60	± 1.38
160 mg Elinzanetant (BAY3427080)	-1.40	± 2.40

Week 16: Change from baseline

Group	Value	95% CI
Placebo	-1.08	± 1.30
40 mg Elinzanetant (BAY3427080)	-0.96	± 1.91
80 mg Elinzanetant (BAY3427080)	-0.31	± 2.90
120 mg Elinzanetant (BAY3427080)	-1.05	± 1.30
160 mg Elinzanetant (BAY3427080)	-0.32	± 2.10

Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 Secondary · From baseline to Weeks 1, 2, 4, 8, 12 and 16

Subjects were provided with an eDiary to document the number of night-time awakenings (NTA). Each evening, subjects recorded the total number of hot flashes of each severity experienced that day since waking. Each morning upon waking, subjects recorded the number of times they woke up in the night and the total number of hot flushes of each severity experienced during the night. Night-time awakenings secondary to hot flashes corresponded to severe hot flash recorded on the morning diary, and all NTAs corresponded to the data recorded in the "Total number of times you woke up last night?" field

Baseline

Group	Value	95% CI
Placebo	2.90	± 1.64
40 mg Elinzanetant (BAY3427080)	2.41	± 1.57
80 mg Elinzanetant (BAY3427080)	4.05	± 1.86
120 mg Elinzanetant (BAY3427080)	2.76	± 1.71
160 mg Elinzanetant (BAY3427080)	2.57	± 1.54

Week 1: Change from baseline

Group	Value	95% CI
Placebo	-0.57	± 0.96
40 mg Elinzanetant (BAY3427080)	-0.52	± 1.07
80 mg Elinzanetant (BAY3427080)	-0.63	± 1.53
120 mg Elinzanetant (BAY3427080)	-0.90	± 1.03
160 mg Elinzanetant (BAY3427080)	-0.68	± 1.14

Week 2: Change from baseline

Group	Value	95% CI
Placebo	-0.69	± 1.03
40 mg Elinzanetant (BAY3427080)	-0.75	± 1.18
80 mg Elinzanetant (BAY3427080)	-1.13	± 1.89
120 mg Elinzanetant (BAY3427080)	-1.18	± 1.27
160 mg Elinzanetant (BAY3427080)	-0.92	± 1.38

Week 4: Change from baseline

Group	Value	95% CI
Placebo	-0.89	± 1.08
40 mg Elinzanetant (BAY3427080)	-0.91	± 1.26
80 mg Elinzanetant (BAY3427080)	-1.33	± 2.27
120 mg Elinzanetant (BAY3427080)	-1.53	± 1.19
160 mg Elinzanetant (BAY3427080)	-1.01	± 1.62

Week 8: Change from baseline

Group	Value	95% CI
Placebo	-1.09	± 1.36
40 mg Elinzanetant (BAY3427080)	-1.50	± 1.40
80 mg Elinzanetant (BAY3427080)	-1.69	± 2.21
120 mg Elinzanetant (BAY3427080)	-1.79	± 1.35
160 mg Elinzanetant (BAY3427080)	-1.13	± 1.86

Week 12: Change from baseline

Group	Value	95% CI
Placebo	-1.31	± 1.39
40 mg Elinzanetant (BAY3427080)	-1.63	± 1.46
80 mg Elinzanetant (BAY3427080)	-1.70	± 2.53
120 mg Elinzanetant (BAY3427080)	-1.67	± 1.27
160 mg Elinzanetant (BAY3427080)	-1.32	± 1.75

Week 16: Change from baseline

Group	Value	95% CI
Placebo	-1.05	± 1.19
40 mg Elinzanetant (BAY3427080)	-1.29	± 1.63
80 mg Elinzanetant (BAY3427080)	-0.45	± 2.05
120 mg Elinzanetant (BAY3427080)	-1.19	± 1.23
160 mg Elinzanetant (BAY3427080)	-0.44	± 1.62

Adverse events — posted to ClinicalTrials.gov

Time frame: On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 2/47 (4%)

Deaths: 0/47

40 mg Elinzanetant (BAY3427080)

Serious: 0/31 (0%)

Deaths: 0/31

80 mg Elinzanetant (BAY3427080)

Serious: 1/17 (6%)

Deaths: 0/17

120 mg Elinzanetant (BAY3427080)

Serious: 1/52 (2%)

Deaths: 0/52

160 mg Elinzanetant (BAY3427080)

Serious: 1/52 (2%)

Deaths: 0/52

Serious adverse events (5 terms)

Reaction	System	Placebo	40 mg Elinzanetant (BAY342…	80 mg Elinzanetant (BAY342…	120 mg Elinzanetant (BAY34…	160 mg Elinzanetant (BAY34…
Sepsis	Infections and infestations	—	—	—	—	—
Tooth abscess	Infections and infestations	—	—	—	—	—
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	—	—	—	—	—
Migraine	Nervous system disorders	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—

Other adverse events (29 terms — click to expand)

Reaction	System	Placebo	40 mg Elinzanetant (BAY342…	80 mg Elinzanetant (BAY342…	120 mg Elinzanetant (BAY34…	160 mg Elinzanetant (BAY34…
Headache	Nervous system disorders	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—	—	—	—
Depressed mood	Psychiatric disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—
Viral sinusitis	Infections and infestations	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Electrocardiogram QT prolonged	Investigations	—	—	—	—	—
Liver function test increased	Investigations	—	—	—	—	—
Joint swelling	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—
Breast tenderness	Reproductive system and breast disorders	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—

Most-reported serious reactions: Sepsis, Tooth abscess, Infective exacerbation of chronic obstructive airways disease, Migraine, Nephrolithiasis.

Data from ClinicalTrials.gov NCT03596762 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial.
Trower M, Anderson RA, Ballantyne E, Joffe H, et al · · 2020 · cited 54× · PMID 32068688 · DOI 10.1097/gme.0000000000001500
Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1).
Simon JA, Anderson RA, Ballantyne E, Bolognese J, et al · · 2023 · cited 50× · PMID 36720081 · DOI 10.1097/gme.0000000000002138
Management of menopausal hot flushes. Recommendations from the Spanish Menopause Society.
Fasero M, Sanchez M, Baquedano L, Gippini I, et al · · 2025 · cited 4× · PMID 39944633 · DOI 10.1016/j.eurox.2025.100366
Psychometric evaluation of the HFDD, PROMIS SD SF 8b, and MENQOL questionnaire in women experiencing vasomotor symptoms associated with menopause.
Trigg A, Barclay M, Whyman S, Lehane A, et al · · 2025 · cited 1× · PMID 40332718 · DOI 10.1186/s41687-025-00875-4
Elinzanetant: First Approval.
Lee A. · · 2026 · PMID 41222830 · DOI 10.1007/s40265-025-02244-3

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03596762 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 10 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03596762.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03596762: SWITCH-1

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (5 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Elinzanetant (BAY3427080)

Other recruiting trials for Menopause

Other Bayer trials

Verify against primary sources