Elinzanetant (BAY3427080) Clinical Trials

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

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18
Total Trials
1
Recruiting
16
Completed
2,611
Total Enrollment
1
States
Elinzanetant (BAY3427080) Evidence & Publications

4 peer-reviewed publications + per-arm primary-outcome data from 11 pivotal trials.

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Elinzanetant (BAY3427080) Clinical Trials

Sortable list of all 18 Elinzanetant (BAY3427080) trials — recruiting status, pivotal acronyms, indication grouping, NCT links.

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What Is Elinzanetant (BAY3427080)?

Elinzanetant (BAY3427080) is an investigational drug currently under study for the treatment of symptoms caused by hormonal changes. Researchers are looking for a better way to treat people who experience symptoms such as hot flashes, night sweats, and other vasomotor symptoms. These symptoms commonly occur in women during menopause, but can also be caused by other hormonal shifts or medical treatments like adjuvant endocrine therapy for breast cancer.

Before a new treatment can be approved for patients, clinical studies are conducted to thoroughly understand its safety and how it works in the body. Elinzanetant is administered orally, and various doses are being investigated in these trials. The goal of its development is to provide a new option for managing the discomfort and impact of these hormone-related symptoms.

Uses and Conditions Under Study

Elinzanetant (BAY3427080) is being investigated for several conditions primarily related to hormonal changes and their associated symptoms. The majority of studies focus on vasomotor symptoms, which are physical reactions to changes in blood vessel diameter.

  • Hot Flashes and Vasomotor Symptoms: Elinzanetant is extensively studied for hot flashes and general vasomotor symptoms. These include conditions like hot flashes (11 trials), vasomotor symptoms as a sex hormone-dependent disorder in women and men (11 trials), vasomotor symptoms associated with menopause (3 trials), menopause-related hot flashes (1 trial), and menopause (1 trial). Researchers are exploring how Elinzanetant might reduce the frequency and severity of these disruptive symptoms, which are often linked to hormonal shifts during menopause.

  • Sleep Disturbances: The drug is also being investigated for sleep disturbances associated with menopause (1 trial) and night waking (1 trial). These sleep issues are often a direct consequence of hot flashes and night sweats, and improving vasomotor symptoms could indirectly alleviate sleep problems.

  • Vasomotor Symptoms in Breast Cancer Patients: One trial is specifically examining vasomotor symptoms caused by adjuvant endocrine therapy in women with, or at high risk for developing, hormone-receptor positive breast cancer. This highlights a potential use for patients who may not be able to use traditional hormone replacement therapies.

  • Healthy Volunteers: Elinzanetant has also been studied in healthy volunteers (4 trials). These studies typically assess the drug's safety, how it is absorbed, distributed, metabolized, and eliminated by the body, and how different doses affect these processes.

Dosing

Elinzanetant (BAY3427080) is administered orally, typically as a capsule. Clinical trials have explored various strengths and dosing regimens to determine the most effective and safe treatment approach.

Different strengths of Elinzanetant have been studied, including single and multiple doses. Investigated strengths include 40 mg, 80 mg, 120 mg, and 160 mg. One common regimen under investigation involves taking 120 mg of Elinzanetant orally once daily for a duration of 12 weeks.

Studies have also examined how Elinzanetant interacts with other medications, such as moxifloxacin and rosuvastatin. Furthermore, research has been conducted to understand how the drug's effects might differ in participants with moderate or severe renal impairment compared to those with normal renal function. These studies help to establish appropriate dosing guidelines for a broad range of patients.

Side Effects

In clinical trials involving patients taking Elinzanetant (BAY3427080), the most commonly reported side effects were:

  • Headache: 7.5% of patients taking Elinzanetant (BAY3427080) experienced headache, compared to 5.5% on placebo. This data was collected across 6 trials involving 3958 patients in the drug arm.
  • Arthralgia (joint pain): 6.3% of patients on Elinzanetant (BAY3427080) reported joint pain, compared to 3.9% on placebo. This was observed in 3 trials with 2740 patients in the drug arm.
  • Somnolence (drowsiness): 6.2% of patients taking Elinzanetant (BAY3427080) experienced drowsiness, compared to 2.2% on placebo. This data comes from 4 trials with 2468 patients in the drug arm.
  • Fatigue: 5.4% of patients on Elinzanetant (BAY3427080) reported fatigue, compared to 2.2% on placebo. This was seen across 6 trials with 3958 patients in the drug arm.
  • Diarrhea: 4.5% of patients taking Elinzanetant (BAY3427080) experienced diarrhea, compared to 2.7% on placebo. This was reported in 3 trials with 2155 patients in the drug arm.
  • Depression: 4.0% of patients on Elinzanetant (BAY3427080) reported depression, compared to 1.0% on placebo. This was observed in 1 trial with 1948 patients in the drug arm.
  • Urinary tract infection: 3.9% of patients taking Elinzanetant (BAY3427080) experienced a urinary tract infection, compared to 1.0% on placebo. This data comes from 2 trials with 207 patients in the drug arm.
  • Back pain: 3.8% of patients on Elinzanetant (BAY3427080) reported back pain, compared to 2.5% on placebo. This was observed in 2 trials with 2003 patients in the drug arm.
  • Asthenia (lack of energy): 3.7% of patients taking Elinzanetant (BAY3427080) experienced asthenia, compared to 1.6% on placebo. This was reported in 1 trial with 1948 patients in the drug arm.

Clinical Trial Results

Clinical trials have investigated the effectiveness and safety of Elinzanetant (BAY3427080) in treating vasomotor symptoms (hot flashes) in post-menopausal women and women with breast cancer receiving anti-cancer therapy. The results below focus on key efficacy and patient-reported outcomes.

Hot Flash Frequency and Severity

In a study (NCT03596762) of post-menopausal women, Elinzanetant (BAY3427080) significantly reduced the frequency and severity of moderate to severe hot flashes compared to placebo. At Week 12:

  • Patients on 120 mg Elinzanetant (BAY3427080) experienced a mean reduction of 7.91 hot flashes per day from a baseline of 13.54, compared to a 4.49 hot flash reduction on placebo from a baseline of 11.82.
  • For hot flash severity, 120 mg Elinzanetant (BAY3427080) led to a mean reduction of 0.56 units on a scale from a baseline of 2.54, compared to a 0.41 unit reduction on placebo from a baseline of 2.54.

Responder rates at Week 12 in this study showed that 61.5% of patients on 120 mg Elinzanetant (BAY3427080) achieved at least a 50% reduction in daily hot flash frequency, compared to 37.0% on placebo. Furthermore, 30.8% of patients on 120 mg Elinzanetant (BAY3427080) achieved at least an 80% reduction, compared to 17.4% on placebo.

Similar reductions in moderate to severe hot flash frequency were observed in other trials, typically with greater reductions for Elinzanetant (BAY3427080) compared to placebo at Week 12:

  • In NCT05030584, Elinzanetant (BAY3427080) reduced hot flashes by 5.40 per day (baseline 6.71), versus 3.50 per day for placebo (baseline 6.81).
  • In NCT05042362, 120 mg Elinzanetant (BAY3427080) reduced hot flashes by 8.74 per day (baseline 13.38), versus 5.53 per day for placebo (baseline 14.26).
  • In NCT05099159, 120 mg Elinzanetant (BAY3427080) reduced hot flashes by 9.96 per day (baseline 14.66), versus 7.24 per day for placebo (baseline 16.16).
  • In NCT05587296 (women with breast cancer), Elinzanetant (BAY3427080) reduced hot flashes by 7.76 per day (baseline 11.41), versus 4.20 per day for placebo (baseline 11.52).

Sleep Disturbances

Improvements in sleep disturbance were also noted. At Week 12:

  • In NCT03596762, 120 mg Elinzanetant (BAY3427080) led to a mean reduction of 6.12 units in the Insomnia Severity Index (ISI) score (baseline 12.63), compared to a 1.95 unit reduction on placebo (baseline 12.43).
  • In NCT05042362, 120 mg Elinzanetant (BAY3427080) showed a mean reduction of 10.8 T-score units in the PROMIS Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) (baseline 61.0), compared to a 5.0 T-score unit reduction on placebo (baseline 60.2).

    • Currently Recruiting Trials

    Elinzanetant (BAY3427080) is currently being investigated in clinical trials to understand its potential benefits for patients. These studies aim to gather more information about how the drug works and for whom it might be most effective.

    One such study, titled "Finding Links Between Hot flASHes and CardioVascular Disease," is identified as NCT07077395. This Phase 2 clinical trial, sponsored by Massachusetts General Hospital, is designed to explore whether elinzanetant can improve blood vessel health in women who experience moderate to severe hot flashes related to menopause. Participants in this study will receive elinzanetant at a dosage of 120 mg daily for a period of 12 weeks. The trial aims to enroll up to 80 participants to help answer key questions about the drug's impact on cardiovascular health in this population.

    Where to Participate

    Participation in the currently recruiting clinical trial for Elinzanetant is focused in a specific geographic area. The study, NCT07077395, is being conducted at 2 sites within a single city and state.

    The primary location for this research is:

    • Boston, Massachusetts

    To be eligible for this particular study, participants must meet specific criteria. Individuals must be female and fall within an age range of 40 to 65 years. The trial is not open to healthy volunteers or children, as it specifically targets women experiencing menopause-related hot flashes.

    Development Timeline

    The development journey for Elinzanetant (BAY3427080) began on July 24, 2018, with Bayer as the primary driving force behind its research, sponsoring 17 out of 18 trials. Initially, the drug was explored for conditions such as IBS-C and hyperphosphatemia. Over time, the research pipeline significantly expanded.

    Elinzanetant's development progressed through various phases, with 11 trials conducted in Phase 1, 3 trials in Phase 2, and 4 trials reaching Phase 3. The scope of conditions under investigation broadened to include healthy volunteers and, notably, a strong focus on menopause-related symptoms. This expansion encompassed vasomotor symptoms associated with menopause, sleep disturbances associated with menopause, and hot flashes. Furthermore, its potential was explored for vasomotor symptoms caused by adjuvant endocrine therapy in women with, or at high risk for developing, hormone-receptor positive breast cancer, and night waking.

    To date, a total of 18 clinical trials have been initiated for Elinzanetant, collectively enrolling approximately 2,611 participants. The latest trial is projected to conclude by July 22, 2025, indicating ongoing and active research into the drug's therapeutic applications. Massachusetts General Hospital has also contributed to this research, sponsoring one of the trials.

Elinzanetant (BAY3427080) Development Timeline

Clinical trial activity from 2018 to 2026.

2026
NCT07077395PHASE2recruiting
Finding Links Between Hot flASHes and CardioVascular Disease
80 enrolled
2024
NCT06219902PHASE1completed
A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women
64 enrolled
2023
NCT06112756PHASE2completed
A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
110 enrolled
2022
NCT05587296PHASE3active not recruiting
A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
474 enrolled
NCT05481528PHASE1completed
A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants
51 enrolled
NCT05471817PHASE1completed
A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female Participants
20 enrolled
NCT05381142PHASE1completed
A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years
16 enrolled
NCT05351892PHASE1completed
A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants
18 enrolled
2021
NCT05099159PHASE3completed
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)
400 enrolled
NCT05071729PHASE1completed
A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally
31 enrolled
NCT05061563PHASE1completed
A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults
14 enrolled
NCT05028608PHASE1completed
A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years.
16 enrolled
NCT05042362PHASE3completed
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause
396 enrolled
NCT05030584PHASE3completed
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause
628 enrolled
NCT04981431PHASE1completed
A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female Adults
62 enrolled
NCT04889287PHASE1completed
A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy Participants
16 enrolled
NCT04845841PHASE1completed
Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body
16 enrolled
2018
NCT03596762PHASE2completed
A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms
199 enrolled

Conditions Under Study

ConditionNCT IDTitleStatusPhaseEnrollment
Hot FlashesNCT06219902A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy WomencompletedPHASE164
NCT05587296A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Canceractive not recruitingPHASE3474
NCT05481528A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy ParticipantscompletedPHASE151
NCT05471817A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female ParticipantscompletedPHASE120
NCT05381142A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 YearscompletedPHASE116
NCT05351892A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male ParticipantscompletedPHASE118
NCT05099159A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)completedPHASE3400
NCT05061563A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy AdultscompletedPHASE114
NCT05042362A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the MenopausecompletedPHASE3396
NCT05030584A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the MenopausecompletedPHASE3628
NCT03596762A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor SymptomscompletedPHASE2199
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenNCT06219902A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy WomencompletedPHASE164
NCT05481528A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy ParticipantscompletedPHASE151
NCT05471817A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female ParticipantscompletedPHASE120
NCT05381142A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 YearscompletedPHASE116
NCT05351892A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male ParticipantscompletedPHASE118
NCT05071729A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work NormallycompletedPHASE131
NCT05061563A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy AdultscompletedPHASE114
NCT05028608A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years.completedPHASE116
NCT04981431A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female AdultscompletedPHASE162
NCT04889287A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy ParticipantscompletedPHASE116
NCT04845841Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the BodycompletedPHASE116
Healthy VolunteersNCT05481528A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy ParticipantscompletedPHASE151
NCT05471817A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female ParticipantscompletedPHASE120
NCT05381142A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 YearscompletedPHASE116
NCT05351892A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male ParticipantscompletedPHASE118
Vasomotor Symptoms Associated With MenopauseNCT05099159A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)completedPHASE3400
NCT05042362A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the MenopausecompletedPHASE3396
NCT05030584A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the MenopausecompletedPHASE3628
Sleep Disturbances Associated With MenopauseNCT06112756A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With MenopausecompletedPHASE2110
Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast CancerNCT05587296A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Canceractive not recruitingPHASE3474
MenopauseNCT03596762A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor SymptomscompletedPHASE2199
Menopause-related Hot FlashesNCT07077395Finding Links Between Hot flASHes and CardioVascular DiseaserecruitingPHASE280
Night WakingNCT03596762A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor SymptomscompletedPHASE2199

All Elinzanetant (BAY3427080) Clinical Trials (18)

NCT IDTitleStatusPhaseEnrollmentSponsor
NCT07077395Finding Links Between Hot flASHes and CardioVascular DiseaserecruitingPHASE280Massachusetts General Hospital
NCT06219902A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy WomencompletedPHASE164Bayer
NCT06112756A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With MenopausecompletedPHASE2110Bayer
NCT05587296A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Canceractive not recruitingPHASE3474Bayer
NCT05481528A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy ParticipantscompletedPHASE151Bayer
NCT05471817A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female ParticipantscompletedPHASE120Bayer
NCT05381142A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 YearscompletedPHASE116Bayer
NCT05351892A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male ParticipantscompletedPHASE118Bayer
NCT05099159A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)completedPHASE3400Bayer
NCT05071729A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work NormallycompletedPHASE131Bayer
NCT05061563A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy AdultscompletedPHASE114Bayer
NCT05028608A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years.completedPHASE116Bayer
NCT05042362A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the MenopausecompletedPHASE3396Bayer
NCT05030584A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the MenopausecompletedPHASE3628Bayer
NCT04981431A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female AdultscompletedPHASE162Bayer
NCT04889287A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy ParticipantscompletedPHASE116Bayer
NCT04845841Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the BodycompletedPHASE116Bayer
NCT03596762A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor SymptomscompletedPHASE2199Bayer

Sponsors

  • Bayer(17 trials · industry)
  • Massachusetts General Hospital(1 trial · other)

Where to Participate: All Elinzanetant (BAY3427080) Trial Sites in the U.S. (2 sites across 1 state)

Every actively recruiting Elinzanetant (BAY3427080)trial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

StateFacilityCityTrialMap
MABrigham and Women's HospitalBoston02115NCT07077395Map
MAMassachusetts General HospitalBoston02114NCT07077395Map

Browse Elinzanetant (BAY3427080) Trials by State

Massachusetts clinical trials
elinzanetant (bay3427080)hot flashesvasomotor symptoms as a sex hormone-dependent disorder in women and menhealthy volunteersvasomotor symptoms associated with menopausesleep disturbances associated with menopauseclinical trials
Data sourced from the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI). Report generated .