Trial · NCT02865538
Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms
NCT02865538, Phase 1, Phase 2, Completed, Bayer; results first posted 2021-02-16
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms. Trials, record NCT02865538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02865538
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms
- NCT number
- NCT02865538
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Post-menopausal Vasomotor Symptoms
- Interventions
- BAY3427080, Placebo (for BAY3427080)
- First posted
- 2016-08-12
- Last updated
- 2025-02-07
- Results first posted
- 2021-02-16
Source ClinicalTrials.gov
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Cmax is the maximum observed plasma concentration of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. |
| Primary | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Time of occurrence of Cmax.Time to reach maximum plasma concentration of BAY3427080 was presented. Blood samples for Tmax were taken within 30 minutes prior to dose administration. |
| Primary | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080 | Day 1 (pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours) | AUC from time zero extrapolated to infinity of BAY3427080 was presented. AUC0-∞ was only estimated following the Day 1 dose. |
| Primary | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Area under the concentration-time curve (AUC) from time zero to the time of the last quantifiable concentration of BAY3427080 was presented. Blood samples for (AUC0-τ) were taken within 30 minutes prior to dose administration. |
| Primary | Terminal Elimination Half-life (t½) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Terminal elimination half-life of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. |
| Primary | Apparent Clearance (CL/F) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Apparent clearance of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. |
| Primary | Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination. | At day 14 | A physician or appropriately qualified delegate conducted a full physical examination. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant). |
| Primary | Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs | At day 14 | Reported results are cardiovascular system-examination findings at day 14. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant). |
| Primary | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Baseline (day -1) and day 14 | Holter monitors were supplied by iCardiac Technologies. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14 and remained in place until 24-hour assessments were completed. |
| Primary | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Baseline and day 14 | Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position. |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 registered outcomesOutcomes55
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Participants who received placebo were not included in the PK population. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Participants who received placebo were not included in the PK population. | hr | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080 | Day 1 (pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours) | Participants in PK population with available data are reported. Participants who received placebo were not included in the PK population. | hr*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Participants who received placebo were not included in the PK population. | hr*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Terminal Elimination Half-life (t½) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Participants in PK population with available data are reported. Participants who received placebo were not included in the PK population. | hr | GEOMETRIC_MEAN |
| PRIMARY | Apparent Clearance (CL/F) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Participants who received placebo were not included in the PK population. | L/hr | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination. | At day 14 | Participants | NUMBER | |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs | At day 14 | Participants | NUMBER | |
| PRIMARY | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Baseline (day -1) and day 14 | Participants | NUMBER | |
| PRIMARY | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Baseline and day 14 | mmHg | MEAN |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 outcomesResults by group1,587
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | 50 mg BAY3427080 | Day 1 | 502.62 | Geometric Coefficient of Variation 90.19 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | 100 mg BAY3427080 | Day 1 | 731.69 | Geometric Coefficient of Variation 110.58 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | 150 mg BAY3427080 | Day 1 | 911.48 | Geometric Coefficient of Variation 148.28 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | 300 mg BAY3427080 | Day 1 | 1576.01 | Geometric Coefficient of Variation 90.70 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | 50 mg BAY3427080 | Day 7 | 548.60 | Geometric Coefficient of Variation 57.47 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | 100 mg BAY3427080 | Day 7 | 809.48 | Geometric Coefficient of Variation 116.58 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | 150 mg BAY3427080 | Day 7 | 1173.50 | Geometric Coefficient of Variation 95.14 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | 300 mg BAY3427080 | Day 7 | 2045.61 | Geometric Coefficient of Variation 152.87 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | 50 mg BAY3427080 | Day 14 | 522.36 | Geometric Coefficient of Variation 87.88 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | 100 mg BAY3427080 | Day 14 | 841.42 | Geometric Coefficient of Variation 107.16 | ng/mL |
1 to 10 of 1,587Source ClinicalTrials.gov
See all 1,587 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Comparator | 18 | |
| Overall Study | STARTED | 50 mg BAY3427080 | 15 | |
| Overall Study | STARTED | 100 mg BAY3427080 | 15 | |
| Overall Study | STARTED | 150 mg BAY3427080 | 15 | |
| Overall Study | STARTED | 300 mg of BAY3427080 | 13 | |
| Overall Study | COMPLETED | Placebo Comparator | 17 | |
| Overall Study | COMPLETED | 50 mg BAY3427080 | 15 | |
| Overall Study | COMPLETED | 100 mg BAY3427080 | 14 | |
| Overall Study | COMPLETED | 150 mg BAY3427080 | 15 | |
| Overall Study | COMPLETED | 300 mg of BAY3427080 | 13 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events185
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrioventricular block first degree | Cardiac disorders | Placebo Comparator | 0 | 18 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | 50 mg BAY3427080 | 0 | 15 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | 100 mg BAY3427080 | 1 | 15 | 1 |
| other | Atrioventricular block first degree | Cardiac disorders | 150 mg BAY3427080 | 0 | 15 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | 300 mg BAY3427080 | 0 | 13 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo Comparator | 1 | 18 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | 50 mg BAY3427080 | 0 | 15 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | 100 mg BAY3427080 | 0 | 15 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | 150 mg BAY3427080 | 0 | 15 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | 300 mg BAY3427080 | 0 | 13 | 0 |
1 to 10 of 185Source ClinicalTrials.gov
See all 185 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Comparator | 0 | 18 |
| Total, all-cause mortality | 50 mg BAY3427080 | 0 | 15 |
| Total, all-cause mortality | 100 mg BAY3427080 | 0 | 15 |
| Total, all-cause mortality | 150 mg BAY3427080 | 0 | 15 |
| Total, all-cause mortality | 300 mg BAY3427080 | 0 | 13 |
| Total, other adverse events | Placebo Comparator | 13 | 18 |
| Total, other adverse events | 50 mg BAY3427080 | 7 | 15 |
| Total, other adverse events | 100 mg BAY3427080 | 11 | 15 |
| Total, other adverse events | 150 mg BAY3427080 | 10 | 15 |
| Total, other adverse events | 300 mg BAY3427080 | 11 | 13 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32068688 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02865538
GET https://conductscience.org/api/trials/v1/NCT02865538/registered?page=2