A Randomized, Double-blind, Placebo- and Active-controlled, 4-period, Crossover Study to Investigate Effects of Elinzanetant on Simulated Driving Performance and Cognitive Function in Healthy Women

Researchers are looking for a better way to treat vasomotor symptoms (VMS), also known as hot flashes.
Hot flashes are intense and sudden feelings of heat along with sweating and reddening of the skin. These are common for women going through the menopause but can also occur in men. Such symptoms are called VMS and are caused by changes in sex hormone levels.
The study treatment, elinzanetant, is being tested for the treatment of VMS in both men and women. It works by blocking the activity of a substance called neurokinin, which is thought to play a role in starting hot flashes.
Elinzanetant may cause lasting effects like sleepiness and tiredness. Such effects may make driving unsafe.
The main purpose of this study is to learn how elinzanetant affects the ability to drive the next day in healthy women.
For this, researchers will study participants' ability to keep a stable position within their lane while driving on a straight road on a computer-based driving test (also known as a driving simulator).
In this study, participants will take 2 different doses of elinzanetant, another drug called zopiclone, and matching placebos to these drugs.
Zopiclone helps treat sleeping problems. A placebo looks like a study drug but does not have any medicine in it.
Participants will take elinzanetant, zopiclone, and their matching placebos by mouth.
This study will have 4 treatment periods with each period lasting 6 days. In each period, participants will receive one of the following treatments in an order assigned to them randomly (by chance):
dose A of elinzanetant and a zopiclone placebo
dose B of elinzanetant and a zopiclone placebo
zopiclone 7.5 milligrams (mg) and elinzanetant placebo
elinzanetant placebo and zopiclone placebo
Each participant will be in the study for around 15 weeks with up to 6 visits to the study site.
Participants will visit the study site:
once before the treatment starts, so the study doctors and their team can check on their health and confirm if the participant can join the study
once in each of the 4 treatment periods for a 6-day stay at the study site with a gap of 14 days between each period. During each stay, they will take the assigned treatment from Days 1 to 5 and the driving test on Days 2 and 6
once, 2 to 3 days after their last treatment so the study doctors and their team can check on their health
During the study, the doctors and their study team will:
check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
check the participants' ability to drive and their brain function and level of sleepiness using different tests including a driving simulator test
check the level of the study drugs in participants' blood
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment or not.

Start Date08 Jan 2024

Sponsor / Collaborator

Bayer AG

NCT06112756 / RecruitingPhase 2

A Randomized, Parallel-group Treatment, Phase 2, Double-blind Pilot Study to Investigate the Efficacy and Safety of Elinzanetant Compared With Placebo for Treatment of Sleep Disturbances Associated With Menopause.

Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause.
Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, for example, frequent waking up at night, are a common and bothersome symptom associated with menopause that affects women's quality of life.
The study treatment Elinzanetant (also called BAY 3427080) is under development to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause. It may block the activity of a protein that has been found to contribute to sleep disturbances.
The main purpose of this study is to learn how does elinzanetant affect sleep disturbances associated with menopause as measured on a sleep test called polysomnography (PSG) as compared with placebo.
For this, the researchers will analyze
change in the total number of minutes a participant wakes up at night after going to sleep after 4 weeks of treatment compared to before treatment
change in the total number of minutes a participant wakes up at night after going to sleep after 12 weeks of treatment compared to before treatment
change in the participant's total time asleep while in bed after 4 and 12 weeks of treatment compared to before treatment.
The study participants will be randomly (by chance) assigned to one of two treatment groups. Dependent on the group, they will take elinzanetant or placebo for 12 weeks.
Each participant will be in the study for approximately 22 weeks (plus potential washout period), including a screening phase of up to 6 weeks, 12 weeks of treatment, and a follow up phase of 4 weeks after the end of treatment. 5 visits to the study site are planned.
During the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check vital signs
do sleep tests
use an electronic hand-held device to record sleep quality and hot flashes at home
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Start Date08 Nov 2023

Sponsor / Collaborator

Bayer AG

NCT05587296 / Active, not recruitingPhase 3

A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Induced by Adjuvant Endocrine Therapy, Over 52 Weeks and Optionally for Additional 2 Years in Women With Hormone-receptor Positive Breast Cancer:

Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer therapy.
VMS, also called hot flashes, are very common medical problems in women with hormone-receptor (HR)-positive breast cancer, who are receiving anti-cancer therapy. HR-positive breast cancer is a type of breast cancer, which has hormone-receptors (proteins) for female sex hormones estrogen and/or progesterone. These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread. Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer.
It is already known that women with HR-positive breast cancer benefit from this treatment. However, hot flashes are common medical problems related to this therapy. They negatively affect quality of life of many women and may lead to discontinuation (stopping) of this therapy.
The study treatment, elinzanetant is being developed to treat hot flushes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes.
The main purpose of this study is to learn more about how well elinzanetant helps to treat hot flashes caused by anti-cancer therapy in women with or at high risk for developing HR-positive breast cancer compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
To answer this, the doctors will ask the participants to record information about their hot flashes before treatment start and at certain time points during the treatment in an electronic diary. The researchers will then assess possible average changes in number and severity of hot flashes after 4 and 12 weeks of treatment.
To see how safe elinzanetant is compared to placebo. The study will collect information about the number of participants who have medical problems after taking treatment.
The study participants will be randomly (by chance) assigned to 2 treatment groups, A and B. The participants from treatment group A will take elinzanetant. The participants from treatment group B will start with placebo and then switch to elinzanetant.
All participants will continue taking the anti-cancer therapy they have been using when entering the study.
Dependent on the treatment group, the participants will either take elinzanetant or placebo as capsules by mouth once a day. After 12 weeks, the participants who have initially received placebo will switch to take elinzanetant for the remaining 40 weeks.
Each participant will be in the study for approximately 62 weeks. The treatment duration in the study will be 52 weeks. There will be up to 12 visits to the study site and 6 phone calls in between. Participants who completed the 52 weeks treatment phase, will be offered to continue treatment for another 2 years. Visit frequency: every 24 weeks until week 152.
During the study, the participants will:
record information about their hot flashes
answer questions about their quality of life and other symptoms.
The doctors and their study team will:
check the participants health and vital signs
take blood and urine samples
examine heart health using electrocardiogram (ECG)
examine pelvic organs like womb or ovaries using a trans vaginal ultrasound scan to see images of these organs
make images of the breast using x-ray (mammogram), a type of radiation that passes through the body to make images of the inside and/or by using ultrasound (if applicable)
check the health of the participant's cervix (neck of the womb) by taking a small sample of cells (smear test) for an analysis called cervical cytology (if applicable)
take an endometrial biopsy, a small piece of tissue from the lining of the womb (called the endometrium) for analysis.
ask the participants questions about what medicines they are taking and if they are having adverse events.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
About 4 weeks after the participants take their last treatment, the study doctors and their team will check the participants' health.

Start Date14 Oct 2022

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Elinzanetant

100 Translational Medicine associated with Elinzanetant

100 Patents (Medical) associated with Elinzanetant

Literatures (Medical) associated with Elinzanetant

01 Dec 2023·The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians

Fezolinetant: A New Nonhormonal Treatment for Vasomotor Symptoms

Review

Author: Onge, Erin St. ; Phillips, Bradley ; Miller, Lisa

Objective: To review the safety, efficacy, and tolerability of fezolinetant for the treatment of vasomotor symptoms associated with menopause. Data Sources: A literature search was conducted through PubMed using the following search terms: fezolinetant, ES259564, SKYLIGHT, vasomotor symptoms, and menopause. Study Selection and Data Extraction: Selected articles included those which described clinical studies of the pharmacology, pharmacokinetics, efficacy, safety, or tolerability of fezolinetant. Data Synthesis: Fezolinetant works by inhibiting neurokinin B from binding to its receptor in the hypothalamus, thereby decreasing the occurrence of vasomotor symptoms. Clinical trials have demonstrated fezolinetant is superior to placebo in decreasing the frequency and severity of vasomotor symptoms. Common adverse effects associated with the use of fezolinetant include headache and gastrointestinal disturbances, as well as elevations in liver transaminase levels. Conclusions: Clinical practice guidelines for the treatment of vasomotor symptoms associated with menopause recommend hormone therapy as the most effective treatment option. Risks associated with hormone use may limit the use of this option in some patients. Neurokinin B inhibitors, like fezolinetant, target the physiologic cause of vasomotor symptoms. With the approval of fezolinetant, as well as elinzanetant which is currently in phase 3 clinical trials, providers and patients have additional nonhormonal treatment options for vasomotor symptoms associated with menopause.

01 Mar 2023·Menopause (New York, N.Y.)

Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1)

Article

Author: Simon, James A ; Joffe, Hadine ; Seymore, Susan ; Anderson, Richard A ; Pawsey, Steve ; Caetano, Cecilia ; Seitz, Christian ; Ballantyne, Elizabeth ; Bolognese, James ; Zuurman, Lineke ; Panay, Nick ; Trower, Mike ; Kerr, Mary

Abstract:

Objective:

Neurokinin (NK)-3 and NK-1 receptors have been implicated in the etiology of vasomotor symptoms (VMS) and sleep disturbances associated with menopause. This phase 2b, adaptive, dose-range finding study aimed to assess the efficacy and safety of multiple doses of elinzanetant (NT-814), a selective NK-1,3 receptor antagonist, in women experiencing VMS associated with menopause, and investigate the impact of elinzanetant on sleep and quality of life.

Methods:

Postmenopausal women aged 40 to 65 years who experienced seven or more moderate-to-severe VMS per day were randomized to receive elinzanetant 40, 80, 120, or 160 mg or placebo once daily using an adaptive design algorithm. Coprimary endpoints were reduction in mean frequency and severity of moderate-to-severe VMS at weeks 4 and 12. Secondary endpoints included patient-reported assessments of sleep and quality of life.

Results:

Elinzanetant 120 mg and 160 mg achieved reductions in VMS frequency versus placebo from week 1 throughout 12 weeks of treatment. Least square mean reductions were statistically significant versus placebo at both primary endpoint time points for elinzanetant 120 mg (week 4: −3.93 [SE, 1.02], P < 0.001; week 12: −2.95 [1.15], P = 0.01) and at week 4 for elinzanetant 160 mg (−2.63 [1.03]; P = 0.01). Both doses also led to clinically meaningful improvements in measures of sleep and quality of life. All doses of elinzanetant were well tolerated.

Conclusions:

Elinzanetant is an effective and well-tolerated nonhormone treatment option for postmenopausal women with VMS and associated sleep disturbance. Elinzanetant also improves quality of life in women with VMS.

01 May 2013·British journal of clinical pharmacologyQ2 · MEDICINE

Pharmacokinetics and central nervous system effects of the novel dual NK₁/NK₃ receptor antagonist GSK1144814 in alcohol‐intoxicated volunteers

Q2 · MEDICINE

Article

Author: Bullman, Jonathan N. ; te Beek, Erik T. ; van Gerven, Joop M. A. ; Hay, Justin L. ; Burgess, Clare ; Nahon, Kimberly J. ; Klaassen, Erica S. ; Gray, Frank A.

Aims:

Antagonism of both NK1 and NK3 receptors may be an effective strategy in the pharmacotherapy of schizophrenia, drug addiction or depression. GSK1144814 is a novel selective dual NK1/NK3 receptor antagonist. The potential influence of GSK1144814 on the effects of alcohol was investigated.

Methods:

In a blinded, randomized, placebo‐controlled, two period crossover study, the pharmacokinetics and central nervous system (CNS) effects of single oral doses of 200 mg GSK1144814 were evaluated in 20 healthy volunteers, using a controlled alcohol infusion paradigm to maintain stable alcohol concentrations with subsequent analysis of eye movements, adaptive tracking, body sway, visual analogue scales, Epworth sleepiness scale and the verbal visual learning test.

Results:

Frequent adverse effects were mild somnolence, fatigue and headache. Plasma concentration of GSK1144814 in the presence of alcohol was maximal 1.5 h after dose administration. GSK1144814 did not affect alcohol pharmacokinetics. Co‐administration of GSK1144814 and alcohol impaired saccadic reaction time and peak velocity, adaptive tracking, alertness, sleepiness, word recognition and recognition reaction time compared with administration of alcohol alone, but the size of the interaction was small.

Conclusions:

Administration of GSK1144814 in the presence of alcohol was generally well tolerated and not likely to produce clinically relevant additional impairments after alcohol consumption.

News (Medical) associated with Elinzanetant

17 May 2024

·www.fiercebiotech.com

Bayer lifts lid on pivotal data ahead of filings to challenge Astellas for menopause market

Bayer's work to file for approval of elinzanetant is "running at full steam.” Bayer’s master plan for its OASIS program is coming together, with the German drugmaker posting phase 3 data that suggest it could challenge Astellas for a recently unlocked menopause market. The phase 3 data come from the OASIS 1 and 2 studies. Bayer reported the success of the trials in January, and followed up with news of a hit on a third study in March, but kept the data to itself. With Astellas’ Veozah authorized in the treatment of hot flashes associated with menopause, the details will matter if Bayer wins approval for elinzanetant and starts trying to claim a piece of the market. Bayer used the 2024 American College of Obstetricians and Gynecologists annual meeting to reveal the data behind the hits on the co-primary endpoints. Both studies looked at the effect of elinzanetant on the severity and frequency of hot flashes after four weeks and 12 weeks of oral daily doses. In OASIS 1, Bayer reported mean reductions versus placebo in the frequency of hot flashes of 3.29 at Week 4 and 3.22 at Week 12. The Week 4 and Week 12 reductions in frequency in OASIS 2 were 3.04 and 3.24, respectively. Astellas won approval on the strength of phase 3 trials that linked Veozah to placebo-adjusted reductions (PDF) in hot flash frequency of 2.1 and 2.6 at week 4 and 2.6 and 2.5 at week 12. Comparing data across different clinical trials can give misleading impressions but the available evidence suggests Bayer could be competitive. Across OASIS 1 and 2, Bayer reported mean reductions versus placebo for severity of 0.33 and 0.22 at Week 4 and 0.40 and 0.28 at Week 12. Astellas reported placebo-adjusted reductions in severity of 0.2 and 0.3 at both Week 4 and Week 12. Sleep is an area in which elinzanetant may have an edge over Astellas’ neurokinin-3 (NK-3) antagonist Veozah. Elinzanetant acts on both NK-3 and NK-1, a related receptor that research suggests may have effects on insomnia and mood unrelated to menopause. Bayer reported statistically significant improvements in sleep disturbances and menopause-related quality of life. Astellas has also posted positive sleep data. With three phase 3 successes under its belt, Bayer is preparing to file for approval of elinzanetant. Bayer CEO Bill Anderson said “preparations to obtain first market authorizations are running at full steam” on an earnings call this week. The molecule, which Bayer acquired in its KaNDy Therapeutics buyout, is part of a thin late-phase pipeline that needs to offset anticipated generic erosion of Eylea and Xarelto sales.

Phase 3Clinical ResultAcquisition

17 May 2024

·firstwordpharma.com

Bayer's elinzanetant data heats up rivalry with Astellas drug in menopause market

Bayer has unveiled detailed data from two pivotal trials of its investigational menopause drug elinzanetant, setting the stage for a heated commercial battle with Astellas' already approved Veozah (fezolinetant) in the long-neglected vasomotor symptoms (VMS) market.At the American College of Obstetricians and Gynecologists (ACOG) annual meeting, Bayer presented detailed results from the OASIS 1 and 2 studies, demonstrating that the dual neurokinin-1,3 (NK-1,3) receptor antagonist significantly reduced the frequency and severity of moderate-to-severe hot flashes associated with menopause. A total of about 800 post-menopausal women were enrolled across the two studies.Stacking up to VeozahIn OASIS 1, elinzanetant showed significant mean reductions versus placebo in hot flash frequency of 3.29 at week 4 and 3.22 at week 12. For severity, the reductions were 0.33 and 0.40 at those timepoints, respectively.OASIS 2 yielded similar results, with elinzanetant demonstrating significant mean reductions in frequency of 3.04 at week 4 and 3.24 at week 12, and in severity of 0.22 and 0.29, respectively.The data could position elinzanetant as a strong competitor to Veozah, an NK-3 receptor antagonist approved last year for the treatment of VMS. It is also cleared in Europe under the name Veoza. In the SKYLIGHT 1 and SKYLIGHT 2 trials, Astellas' drug reduced hot flash frequency by 2.07 and 2.55 at week 4 and by 2.53 and 2.55 at week 12. Hot flash severity reductions were about 0.20 and 0.29 across the two SKYLIGHT studies, respectively.While efficacy data suggest a closely matched rivalry, other factors could tilt the scales. Bayer said elinzanetant also met key secondary endpoints in OASIS 1 and 2, significantly improving sleep compared to placebo. Mean change from baseline to week 12 on the PROMIS sleep disturbance measure was 5.58 in OASIS 1 and 4.32 in OSAIS 2 in favour of elinzanetant over placebo.No liver injuryStudy drop-outs due to adverse events were higher in the elinzanetant arms than placebo in both studies (8.5% vs 6.7% in OASIS 1; 6.5% vs 2% in OASIS 2).Liver safety has also been a point of concern for Veozah, which requires liver function testing due to possible increases in hepatic serum transaminase levels. However, researchers said there were "no cases of drug-induced liver injury causally related to elinzanetant" or any incidences of endometrial hyperplasia or malignant neoplasm in either of the OASIS studies, according to the ACOG presentations.In a recent interview with FirstWord, Waljit Dhillo, professor of endocrinology and metabolism at Imperial College London, said "it would definitely be a big difference" if elinzanetant avoids such liver monitoring requirements. "If you can just give a tablet and then go away, that would be attractive."Hitting the NK1 receptor could theoretically provide elinzanetant with better liver safety and less sleep disturbance compared to Veozah, which only targets NK3. However, when asked how optimistic he was about whether elinzanetant could necessitate less liver monitoring, Dhillo noted that since there are no NK3 receptors in the liver, any differentiation in liver safety may come down to differences in the specific molecules rather than their receptor targets.FirstWord recently caught up with Astellas leadership to discuss Veozah, including the concerns regarding liver safety. For more on that interview, see – ViewPoints: Having broken ground in untapped menopause market, Astellas outlines strategy for Veozah as competition heats up.First-mover advantage?"The robust efficacy and favourable safety profile of elinzanetant reinforces its potential as a non-hormonal treatment for women experiencing menopause," said Bayer's R&D head Christian Rommel in a company release. Bayer plans to submit elinzanetant's data to regulatory authorities for marketing approval this year, setting up a commercial clash with Astellas' first-mover advantage. "Our preparations to obtain first-market authorisations are running at full steam," Bayer CEO Bill Anderson stated at the company's earning call this week.Bayer would not disclose elinzanetant's price until the FDA clears it, although some analysts suggest it could cost as much as or more than Veozah, which can cost at least $550 for a month's supply.Commenting on the OASIS readouts, Morgan Stanley analysts said that "although elinzanetant appears slightly more effective than Veozah in reducing symptom frequency over 12 weeks, we do not think this will make a big difference in terms of business. Bayer is due to launch the drug in 2025, giving Veozah a two-year advantage."

Clinical ResultDrug Approval

17 May 2024

·www.pharmamanufacturing.com

Bayer shares phase 3 trial wins for menopause symptom drug

Bayer's investigational compound, elinzanetant, significantly reduced frequency and severity of vasomotor symptoms (hot flashes) associated with menopause in a pair of phase 3 trials . Elinzanetant, which offers non-hormonal treatment, successfully met all four primary endpoints in the OASIS 1 and 2 studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms (VMS) from baseline to week 4 and 12 compared to placebo. In addition, elinzanetant met its key secondary endpoints showing a statistically significant reduction in the frequency of VMS from baseline to week 1 and improved sleep disturbances and menopause-related quality of life compared to placebo. Back in March , Bayer announced positive topline results for the third phase 3 study, OASIS 3, in the OASIS clinical development program. In this study, elinzanetant reduced the frequency of hot flashes from baseline to week 12 compared to placebo. Elinzanetant is a dual neurokinin-1,3 (NK-1,3) receptor antagonist, administered orally once daily. The drug is designed to address VMS by modulating a group of estrogen-sensitive neurons in the hypothalamus region of the brain which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, which disrupts body heat control. Bayer plans to submit the data from the three OASIS studies to regulatory authorities for marketing approval. If approved, elinzanetant will join Astellas' Veozah in the menopause symptoms space. Astellas won approval for the once-daily pill, a neurokinin 3 (NK3) receptor antagonist, a year ago .Veozah was the first non-hormonal treatment for moderate to severe vasomotor symptoms associated with menopause.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Elinzanetant

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hormone receptor positive breast cancer	Phase 3	AT	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	BE	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	CA	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	FI	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	FR	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	DE	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	HU	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	IE	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	IL	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	IT	Bayer AG	14 Oct 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05042362 (OASIS-1, Biospace) Manual	Phase 3	Hot Flashes	396	Elinzanetant	nlrhruxygl(vzgmmeofxj) = The safety profile of elinzanetant was favorable in both studies with headache and fatigue being the most frequent treatment emergent adverse events (TEAEs) within the elinzanetant groups. xtpafoumaf (nxbpaixjth )	Positive	16 May 2024
NCT05099159 (OASIS-2, Biospace) Manual	Phase 3	Hot Flashes	400	Elinzanetant	nfggryfvtx(zwdrclboxs) = The safety profile of elinzanetant was favorable in both studies with headache and fatigue being the most frequent treatment emergent adverse events (TEAEs) within the elinzanetant groups. wnzwhhgyvw (cwftahtnvy )	Positive	16 May 2024
NCT05099159 \| NCT05042362 (OASIS 2, PipelineReview) Manual	Phase 3	Vasomotor symptom	400	elinzanetant	edeqpennel(hifvjyumbk) = demonstrating statistically significant reductions lofmvyjoby (blfaqmsipj ) Met View more	Positive	08 Jan 2024
				Placebo
NCT03596762 (CTgov)	Phase 2	Vasomotor symptom \| Hot Flashes \| Dyssomnias	199	Placebo (Placebo)	ojodszhsjo(hgpgfdobqm) = xlhohcirkk absykogyse (lbsnxwktwg, pcwcrwkxpp - lmzdeqzzyx) View more	-	10 Mar 2023
				Elinzanetant (BAY3427080) (40 mg Elinzanetant (BAY3427080))	ojodszhsjo(hgpgfdobqm) = yguzstivkv absykogyse (lbsnxwktwg, bzwodhatth - pywgfejgbo) View more
Pubmed \| J Clin Endocrinol Metab	Not Applicable	-	-	Elinzanetant 120 mg	ennpynuqtk(vgvaoxrfjh) = lkqgaaaalw wtxqntzabd (kykzvusfjx ) View more	-	24 Feb 2021
NCT02865538 (CTgov)	Phase 1/2	Vasomotor symptom	76	placebo+BAY3427080 (Placebo)	lfoswnyqsk(oesakdhrrf) = roepltchle ehfhjywzip (onupizdbbv, iyvwxjqlns - syntpamczc) View more	-	16 Feb 2021
				BAY3427080 (50 mg BAY3427080)	abxbvncppv(voydtueobv) = gwnhjjsrts hykxgcwrvn (raockkvggq, eeigaahikt - onwbiaiymb) View more

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