Vasomotor SymptomsPhase 1NCT07229404
A Study to Investigate Relative Bioavailability, Safety and Tolerability of Single- and Multiple-doses of Elinzanetant in Healthy Female Participants
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Vasomotor Symptoms, run by Bayer at 1 site in Canada.
Trial summary
The aim of this study is to examine the relative bioavailability of elinzanetant when administered in new oral formulations (treatment B and C) after both single and multiple oral doses, compared to its administration in soft gel capsule form (treatment A). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms
- What is being tested?
- Treatment A, Treatment B and Treatment C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2025to 14 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participant between 18 to 65 years of age (inclusive), at the time of signing the informed consent form (ICF).
- Participant is overtly healthy as determined by the investigator (including assessment of medical history, physical examination, blood pressure (BP), pulse rate, 12-lead electrocardiogram (ECG), body temperature, and clinical laboratory).
- Body weight of at least 50 kg and body mass index (BMI) above or equal to 18.0 and below or equal to 32.0 kg/m² at screening.
- Signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention(s) will not be normal.
- Known or suspected allergy or hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g. non-investigational medicinal products, challenge agents, or rescue medication.
- Febrile illness within 2 weeks before the start of the first study intervention.
- History of clinically relevant seizures.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), Bilirubin, or gamma-glutamyl transferase (GGT) > 1.2 x upper limit of normal (ULN).
- Previous (within 30 days before first administration of study intervention) or concomitant participation in another clinical study with study intervention(s).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Combined Single- and Multiple-dose, Open-label, Randomized, 6 x 3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability of Elinzanetant (BAY 3427080) in Healthy Female Participants
The aim of this study is to examine the relative bioavailability of elinzanetant when administered in new oral formulations (treatment B and C) after both single and multiple oral doses, compared to its administration in soft gel capsule form (treatment A).
Study details include:
Read more
An ambulatory screening visit within 4 weeks prior to first treatment. Participants will be admitted to the ward on Day -1 of each period. On Day 1, either treatment B or treatment C will be administered fasted in the evening, followed by blood sampling for a 24-hour pharmacokinetic (PK) profile.
On Day 2, the multiple dosing starts 3 hours after a standardized dinner in the evening.
After the last dosing on Day 7, a complete PK profile for 24 hours will be collected.
If there are no medical objections, participants will be discharged from the study ward on Day 9 in the morning for a washout-out period of at least 10 days (240 hours after last dosing, after period 1 and 2) or, in period 3, after the follow-up examination.
The total duration of the study will be approximately 10 to 12 weeks for each participant.
- Conditions
- Vasomotor Symptoms
- Being tested
- Treatment A, Treatment B, Treatment C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
Elinzanetant (BAY 3427080), dosage 1
Treatment BDrug
Elinzanetant (BAY 3427080), dosage 2
Treatment CDrug
Elinzanetant (BAY 3427080), dosage 3
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Treatments are administered in sequence of A-B-C Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Sequence 2 | Experimental | Treatments are administered in sequence of A-C-B Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Sequence 3 | Experimental | Treatments are administered in sequence of C-A-B Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Sequence 4 | Experimental | Treatments are administered in sequence of C-B-A Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Sequence 5 | Experimental | Treatments are administered in sequence of B-C-A Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Sequence 6 | Experimental | Treatments are administered in sequence of B-A-C Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-24)md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C)
Measured: From Day 0 to Day 8
Cmax,md and Cmin,,md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C)
Measured: From Day 0 to Day 8
Secondary outcomes (3)
AUC(0-24) after single dose in the evening under fasted condition (treatments A, B, C).
Measured: From Day 0 to Day 8
Cmax after single dose in the evening under fasted condition (treatments A, B, C).
Measured: From Day 0 to Day 8
Number and severity of treatment-emergent adverse events (TEAEs) after first study intervention until follow up
Measured: From first dosing up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start5 Nov 2025
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SymptomsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229404
- Sponsor's protocol ID
- 22790
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Single- and Multiple-dose, Open-label, Randomized, 6 x 3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability of Elinzanetant (BAY 3427080) in Healthy Female Participants
- ClinicalTrials.gov ID
- NCT07229404
- Acronym / sponsor ID
- 22790
- Conditions
- Vasomotor Symptoms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine the relative bioavailability of elinzanetant when administered in new oral formulations (treatment B and C) after both single and multiple oral doses, compared to its administration in soft gel capsule form (treatment A).
Study details include:
An ambulatory screening visit within 4 weeks prior to first treatment. Participants will be admitted to the ward on Day -1 of each period. On Day 1, either treatment B or treatment C will be administered fasted in the evening, followed by blood sampling for a 24-hour pharmacokinetic (PK) profile.
On Day 2, the multiple dosing starts 3 hours after a standardized dinner in the evening.
After the last dosing on Day 7, a complete PK profile for 24 hours will be collected.
If there are no medical objections, participants will be discharged from the study ward on Day 9 in the morning for a washout-out period of at least 10 days (240 hours after last dosing, after period 1 and 2) or, in period 3, after the follow-up examination.
The total duration of the study will be approximately 10 to 12 weeks for each participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatments are administered in sequence of A-B-C |
| Sequence 2 | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatments are administered in sequence of A-C-B |
| Sequence 3 | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatments are administered in sequence of C-A-B |
| Sequence 4 | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatments are administered in sequence of C-B-A |
| Sequence 5 | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatments are administered in sequence of B-C-A |
| Sequence 6 | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatments are administered in sequence of B-A-C |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female participant between 18 to 65 years of age (inclusive), at the time of signing the informed consent form (ICF).
- Participant is overtly healthy as determined by the investigator (including assessment of medical history, physical examination, blood pressure (BP), pulse rate, 12-lead electrocardiogram (ECG), body temperature, and clinical laboratory).
- Body weight of at least 50 kg and body mass index (BMI) above or equal to 18.0 and below or equal to 32.0 kg/m² at screening.
- Signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Key exclusion criteria (6 listed)
- Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention(s) will not be normal.
- Known or suspected allergy or hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g. non-investigational medicinal products, challenge agents, or rescue medication.
- Febrile illness within 2 weeks before the start of the first study intervention.
- History of clinically relevant seizures.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), Bilirubin, or gamma-glutamyl transferase (GGT) > 1.2 x upper limit of normal (ULN).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment AElinzanetant (BAY 3427080), dosage 1 | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Treatment BElinzanetant (BAY 3427080), dosage 2 | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Treatment CElinzanetant (BAY 3427080), dosage 3 | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
AUC(0-24)md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C)
Time frame: From Day 0 to Day 8
Cmax,md and Cmin,,md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C)
Time frame: From Day 0 to Day 8
3 secondary outcomes
AUC(0-24) after single dose in the evening under fasted condition (treatments A, B, C).
Time frame: From Day 0 to Day 8
Cmax after single dose in the evening under fasted condition (treatments A, B, C).
Time frame: From Day 0 to Day 8
Number and severity of treatment-emergent adverse events (TEAEs) after first study intervention until follow up
Time frame: From first dosing up to Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Vasomotor Symptoms, run by Bayer at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC(0-24)md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C) (time frame: From Day 0 to Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.