Vasomotor Symptoms as a Sex Hormone-dependent Disorder in WomenPhase 1NCT07762287
Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants
A Phase 1 study testing Elinzanetant (BAY 3427080) treatment A and Elinzanetant (BAY 3427080) treatment B in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women, run by Bayer at 1 site in Canada.
Trial summary
This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an… 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 as a Sex Hormone-dependent Disorder in Women
- What is being tested?
- Elinzanetant (BAY 3427080) treatment A and Elinzanetant (BAY 3427080) treatment B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jul 2026to 22 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 participants aged 18 to 65 years (inclusive) at the time of signing informed consent.
- Participants must be overtly healthy as determined by the investigator based on medical history, physical examination, vital signs, ECG, and clinical laboratory assessments.
- Body weight ≥50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at screening.
- Women of childbearing potential must agree to use a highly effective method of contraception during the study and until 14 days after last administration of study intervention.
- Signed informed consent obtained prior to any study-specific procedures.
Who cannot join
- Diseases or conditions that may affect absorption, distribution, metabolism, elimination, or effects of the study intervention(s).
- Known or suspected hypersensitivity to the study intervention(s) or their excipients.
- Severe allergies or clinically significant hypersensitivity reactions (e.g. allergic asthma, urticaria, or steroid-requiring allergies).
- Febrile illness within 2 weeks prior to first administration of study intervention.
- History of clinically relevant seizures or endometrial tumors.
- Use of moderate or strong CYP3A4 inhibitors or inducers within 4 weeks prior to first study intervention.
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- Participation in another clinical study within 30 days prior to first study intervention or concurrent participation in another trial.
- Clinically relevant abnormal laboratory findings at screening, including elevated liver enzymes or positive virology tests.
- Positive pregnancy test at screening or prior to dosing, or breastfeeding. Positive drug abuse or alcohol test at screening.
- Smoking more than 10 cigarettes per day within 3 months prior to screening.
- Special diets incompatible with study requirements or inability to comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Combined Single- and Multiple-dose, Open-label, Randomized, 2 x 2 Crossover Study to Investigate the Relative Bioavailability of Two Oral Elinzanetant (BAY 3427080) Formulations in Healthy Female Participants
This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form.
About 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.
- Being tested
- Elinzanetant (BAY 3427080) treatment A, Elinzanetant (BAY 3427080) treatment B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elinzanetant (BAY 3427080) treatment ADrug
Elinzanetant treatment A is administered orally once daily.
Elinzanetant (BAY 3427080) treatment BDrug
Elinzanetant treatment B is administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Treatment A followed by Treatment B | Experimental | Participants receive Treatment A followed by Treatment B in a randomized 2 x 2 crossover design with two treatment periods. Receives: Drug: Elinzanetant (BAY 3427080) treatment A; Drug: Elinzanetant (BAY 3427080) treatment B |
| Sequence 2: Treatment B followed by Treatment A | Experimental | Participants receive Treatment B followed by Treatment A in a randomized 2 x 2 crossover design with two treatment periods. Receives: Drug: Elinzanetant (BAY 3427080) treatment A; Drug: Elinzanetant (BAY 3427080) treatment B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md)
elinzanetant administered in the evening 3 hours after a light dinner.
Measured: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
Maximum Observed Plasma Concentration After Multiple Dosing (Cmax,md)
elinzanetant administered in the evening 3 hours after a light dinner.
Measured: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
Minimum Observed Plasma Concentration During Dosing Interval After Multiple Dosing (Cmin,md)
elinzanetant administered in the evening 3 hours after a light dinner.
Measured: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
Secondary outcomes (3)
Number and Severity of Treatment-Emergent Adverse Events (TEAEs)
Measured: From first dose of study intervention through Day 12 of Period 2 (each treatment period is 12 days)
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Single Dose (AUC(0-24))
elinzanetant administered in the evening under fasted conditions.
Measured: On Day 2 of each 12-day treatment period
Maximum Observed Plasma Concentration After Single Dose (Cmax)
elinzanetant administered in the evening under fasted conditions.
Measured: On Day 2 of each 12-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start22 Jul 2026
- Primary completion22 Feb 2027 (estimated)
- Study completion22 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor Symptoms as a Sex Hormone-dependent Disorder in WomenStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762287
- Sponsor's protocol ID
- 22791
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Aug 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, 2 x 2 Crossover Study to Investigate the Relative Bioavailability of Two Oral Elinzanetant (BAY 3427080) Formulations in Healthy Female Participants
- ClinicalTrials.gov ID
- NCT07762287
- Acronym / sponsor ID
- 22791
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- 22 Feb 2027 (estimated)
- Study completion
- 22 Feb 2027 (estimated)
- First posted
- 13 Aug 2026 (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.
This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form.
About 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Treatment A followed by Treatment B | Experimental | Drug: Elinzanetant (BAY 3427080) treatment A, Drug: Elinzanetant (BAY 3427080) treatment BParticipants receive Treatment A followed by Treatment B in a randomized 2 x 2 crossover design with two treatment periods. |
| Sequence 2: Treatment B followed by Treatment A | Experimental | Drug: Elinzanetant (BAY 3427080) treatment A, Drug: Elinzanetant (BAY 3427080) treatment BParticipants receive Treatment B followed by Treatment A in a randomized 2 x 2 crossover design with two treatment periods. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female participants aged 18 to 65 years (inclusive) at the time of signing informed consent.
- Participants must be overtly healthy as determined by the investigator based on medical history, physical examination, vital signs, ECG, and clinical laboratory assessments.
- Body weight ≥50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at screening.
- Women of childbearing potential must agree to use a highly effective method of contraception during the study and until 14 days after last administration of study intervention.
- Signed informed consent obtained prior to any study-specific procedures.
Key exclusion criteria (11 listed)
- Diseases or conditions that may affect absorption, distribution, metabolism, elimination, or effects of the study intervention(s).
- Known or suspected hypersensitivity to the study intervention(s) or their excipients.
- Severe allergies or clinically significant hypersensitivity reactions (e.g. allergic asthma, urticaria, or steroid-requiring allergies).
- Febrile illness within 2 weeks prior to first administration of study intervention.
- History of clinically relevant seizures or endometrial tumors.
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 |
|---|---|---|
| Elinzanetant (BAY 3427080) treatment AElinzanetant treatment A is administered orally once daily. | Drug | Sequence 1: Treatment A followed by Treatment B, Sequence 2: Treatment B followed by Treatment A |
| Elinzanetant (BAY 3427080) treatment BElinzanetant treatment B is administered orally once daily. | Drug | Sequence 1: Treatment A followed by Treatment B, Sequence 2: Treatment B followed by Treatment A |
Primary outcome
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md)
Time frame: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
elinzanetant administered in the evening 3 hours after a light dinner.
Maximum Observed Plasma Concentration After Multiple Dosing (Cmax,md)
Time frame: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
elinzanetant administered in the evening 3 hours after a light dinner.
Minimum Observed Plasma Concentration During Dosing Interval After Multiple Dosing (Cmin,md)
Time frame: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
elinzanetant administered in the evening 3 hours after a light dinner.
3 secondary outcomes
Number and Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study intervention through Day 12 of Period 2 (each treatment period is 12 days)
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Single Dose (AUC(0-24))
Time frame: On Day 2 of each 12-day treatment period
Maximum Observed Plasma Concentration After Single Dose (Cmax)
Time frame: On Day 2 of each 12-day treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 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.
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 Elinzanetant (BAY 3427080) treatment A and Elinzanetant (BAY 3427080) treatment B in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women, 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 13 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md) (time frame: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)). The study lists 3 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 13 Aug 2026.