To be eligible for the trial, patients must be diagnosed with hormone-receptorpositive breast cancer or be at risk for developing the disease. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. November 3, 2022 Brielle Benyon Patients with breast cancer can enroll on a clinical trial analyzing elinzanetant for endocrine therapy-related hot flashes. An expanded clinical trial called OASIS 4 will investigate a new drug, elinzanetant, in treating vasomotor symptoms (hot flashes) in women with breast cancer undergoing endocrine therapy. The total duration of individual study participation will be about 4.5 weeks including the screening period. Uses, Side Effects, & Dosage, What is Aripiprazole? A Randomized, Single-blind, Placebo-controlled Study to Investigate the Pharmacokinetics, Safety and Tolerability of Single and Multiple Doses of Elinzanetant in Chinese Healthy Female Participants 40 to 65 Years of Age, 40 Years to 65 Years (Adult, Older Adult), The First Affiliated Hospital of Guangzhou University of TCM. The purpose of this study is to assess the blood levels of elinzanetant when given as 2 . Any clinically relevant abnormal findings in medical history and physical examination which in the opinion of the investigators, may put the participant at risk because of his/her participation in the trial or provide difficulties in interpreting the trial data. According to Bayer, the manufacturer of elinzantant, hot flashes affect up to 80% of women who are undergoing menopause and can have negative effects of quality of life. History of clinically hepatic disorders including hepatic porphyria (e.g. Treated hypothyroidism with normal thyroid function test results during screening and a stable (for 3 months before signing of informed consent) dose of replacement therapy is acceptable. Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men. 2022 MJH Life Sciences and CURE - Oncology & Cancer News for Patients & Caregivers. This study will provide information on how to use elinzanetant in Chinese people. The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal changes. Up titration of carbamazepine over 4 days (dose 1, 2, 3) continued by fixed dose 3 of carbamazepine prior to administration of midazolam / elinzanetant, followed by carbamazepine administration. Items use a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options are tailored to the aspect of depression being measured in each item. the average total level of dabigatran in the blood (also referred to as AUC) when dabigatran is given alone and is given together with elinzanetant. Carbamazepine given orally twice daily in Period 2 . (Clinical Trial), A Randomized, Double-blind, Placebo- and Moxifloxacin-controlled Study to Investigate the Safety and Pharmacokinetics of Single Ascending Supratherapeutic Doses of Elinzanetant in Healthy Participants, Experimental: Part 2: Moxifloxacin - Placebo, Experimental: Part 2: Placebo - Moxifloxacin. Moderate to severe hot flash (HF) associated with the menopause and seeking treatment for this condition. Each participant will be in the study for approximately 36 weeks. Individual Participant Data (IPD) Sharing Statement: Availability of this study's data later will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". Blood and urine samples will be collected. 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. It is unlikely that a trial like the Women's Health Initiative study, a large observational trial that followed 93,000 participants and revealed some safety risks with hormonal therapies, will happen again, he noted. Before a new treatment can be approved for people to take, researchers perform clinical trials to better understand how this treatment works and to investigate safety. For general information, Learn About Clinical Studies. Participants of this study will be healthy and will have no benefit from administration . To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The clinical Phase III development program with elinzantant, OASIS, currently comprises four Phase III studies: OASIS 1,2,3 and 4. Acute renal failure or acute nephritis within the past 2 years. Intervention Types: Drug, Drug. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. First, a single dose of two capsules is taken by mouth and later multiple doses once a day for another 6 days in a row are taken. Apply to this Phase 4 clinical trial treating Pancreatic Neoplasms, Pancreatic Adenocarcinoma (Ductal Adenocarcinoma). (Clinical Trial), Open-label, Fixed Sequence Crossover Study to Determine the Effects of a Single Dose of Elinzanetant (BAY 3427080) on the Pharmacokinetics of Dabigatran Etexilate in Healthy Participants, 18 Years to 65 Years (Adult, Older Adult), CRS Clinical Research Services Wuppertal GmbH, Wuppertal, Nordrhein-Westfalen, Germany, 42113. Elinzanetant was developed to treat symptoms caused by sex hormonal changes. Elinzanetant will be administered as a single dose on Study Day 1 and a multiple dose once daily for another 6 consecutive days on Study Day 8 to Study Day 13. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Ask the participants questions about their mood and about sleepiness. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure (BP), pulse rate, 12-lead electrocardiogram (ECG), and laboratory tests. An adverse event is any medical problem that a participant has during a study. a serum creatinine value determined 3 or more months before screening (e.g. WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer, a global leader in women's healthcare, announced today that it started the Phase III clinical development program OASIS, which aims to evaluate the efficacy and safety of the investigational compound, elinzanetant for the treatment of vasomotor symptoms during menopause. View this study on Beta.ClinicalTrials.gov. And after 4 days, the participants will take one dose of elinzanetant by mouth and at 30 minutes later, one dose of dabigatran by mouth during the second period of the study. As a so-called substrate of P-gp, dabigatran is typically removed from the body by P-gp transporters. Post-approval clinical surveillance and follow-up registries will likely be more informative, he added. A total score ranging from 0 to 63 is calculated with scores of 0-13 indicating mild minimal range, 14 - 19 mild depression, 20 - 28 indicating moderate and 29 - 63 severe depression (higher score = greater depression). Listing a study does not mean it has been evaluated by the U.S. Federal Government. MyChart is a patient accessible website that enables you to interact with your Baylor Medicine healthcare team. The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal changes. Participants of Dose Groups 1 and 4 will receive a single dose of placebo in Period 1 and a single dose of moxifloxacin in Period 2. AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose. [TimeFrame:After the first administration of study intervention up to 7 days after the last administration]. During this visit, the participants will: The doctors will keep track of any adverse events. Elinzanetant (BAY3427080) Esomeprazole Groningen, Netherlands PRAHealthSciences Mar 16, 2022 Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes, Healthy Volunteers Trial in Miami Completed Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men +2 more Elinzanetant (BAY3427080) Miami, Florida Each participant will be in the study for up to 10 weeks. An expanded clinical trial called OASIS 4 will investigate a new drug, elinzanetant, in treating vasomotor symptoms (hot flashes) in women with breast cancer undergoing endocrine therapy. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people. 2 x 2 Crossover Study to Investigate the Relative Bioavailability, the Safety and the Tolerability of Elinzanetant (BAY 3427080) in . Single oral dose of elinzanetant or placebo. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the treatment in the body. Regular use of therapeutic drugs or supplements, e.g., carnitine products, anabolics, high dose vitamins. Women of childbearing potential will have to use highly effective non-hormonal contraception when having sexual intercourse with a male partner from signing the informed consent form until 5 days after last dose of the study intervention. Any lesion or condition considered a significant risk factor for major bleeding. ask the participants questions about what medicines the participants are taking and if the participants 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. The researchers will study the number of hot flashes the participants have and how severe the hot flashes are. For Research Sites Study Screening Websites A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 52 Weeks in Postmenopausal Women Use of adequate contraception should be consistent with local regulations. 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. Uses, Side Effects, & Dosage, What is Cialis? Neither of the other medications triggered similar concerns, Neal-Perry says. 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. There are treatments for hot flashes in women who have been through the menopause, but may cause . CRS Clinical-Research-Services Mannheim GmbH, Mannheim, Baden-Wrttemberg, Germany, 68167. Services currently available through MyChart include secure messaging with your physician, online appointment requests, prescription renewal, viewing test results, and general health information. Any relevant disease (other than those related to renal impairment for the renal impaired participants) within 4 weeks prior to study drug administration including infections and acute gastro-intestinal diseases (with vomiting, diarrhea, constipation, etc.) Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms (VMS) such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome. Women who no longer have their period may have a protein called neurokinin sending more signals than usual to other parts of the body. St. John's wort within 4 weeks before first study intervention administration. But, the entire study will last about 4 months. Why Should I Register and Submit Results? NK-1 antagonists boost the efficacy of 5-HT3 antagonists to prevent nausea and vomiting. . Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05471817. A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 26 Weeks in Postmenopausal Women This information was retrieved directly from the website clinicaltrials.gov without any changes. Untreated hyperthyroidism or hypothyroidism. Four different increasing doses of elinzanetant will be tested. Find a Doctor; Find a Location; Patient and Visitor Guide; Health Encyclopedia; Jobs; For Employees; Full Site; CONNECT WITH US Clinical trial Trial design and key participant BL data Key outcomes Results (p-values vs. placebo) 1a. Contraindications for the use of moxifloxacin, including: Medical history of seizures or psychiatric disorders, myasthenia gravis, severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN; also known as Lyell's syndrome), Stevens Johnson syndrome (SJS) and Acute Generalized Exanthematous Pustulosis (AGEP), glucose-6-phosphate dehydrogenase deficiency. Please remove one or more studies before adding more. The participants in this study will take two capsules of either elinzanetant or the placebo once a day. Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD]) [TimeFrame:Baseline to Week 4], Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD) [TimeFrame:Baseline to Week 12], Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD) [TimeFrame:Baseline to Week 4], Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD) [TimeFrame:Baseline to Week 12], Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD) [TimeFrame:Baseline to Week 1], Mean change in frequency of moderate to severe HF from baseline over time [TimeFrame:Baseline to Week 26], Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12 [TimeFrame:Baseline to Week 12], Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12 [TimeFrame:Baseline to Week 12], Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12 [TimeFrame:Baseline to Week 12], Mean change in BDI-II total score from baseline to Week 26 [TimeFrame:Baseline to Week 26], at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or, at least 6 months of spontaneous amenorrhea prior to signing of informed consent with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or, at least 6 months after hysterectomy at signing of informed consent with serum FSH levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or. On other days, they will take two study treatments. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05381142. History or evidence of any clinically relevant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other clinically relevant disease, as judged by the investigator. Clinically relevant abnormal findings on mammogram. 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. . Women with mild hypertension can be included in the study if they are medically cleared prior to study participation. Researchers are looking for a better way to treat vasomotor symptoms, a condition of having hot flashes. Check it out and tell us what you think! For general information, Learn About Clinical Studies. 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. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: the average highest level of dabigatran in the blood (also referred to as Cmax). elinzanetant is an orally administered investigational small molecule dual antagonist of both the neurokinin-1 and 3 receptors and is believed to address vasomotor symptoms by modulating a group. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: AUC of elinzanetant with carbamazepine. Body mass index (BMI) within the range 18 - 32 kg/m^2 (inclusive). (Clinical Trial). Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Elinzanetant is already being tested in the OASIS trials for VMS associated with menopause - an indication in which Bayer is in a head-to-head race with Astellas and its fezolinetant drug candidate - and breast cancer could represent a sizeable additional patient population for the drug. A clinical trial for a third candidate drug, pavinetant, was halted . Midazolam is a treatment that is already available for doctors to prescribe as a sedative (calming treatment) or to help people sleep. Tendency for vasovagal reactions or history of syncope. For each item, the participant indicates if they have experienced the symptom (yes/no). Known hypersensitivity to the study interventions (active substances, or excipients of the preparations). An adverse event is any medical problem that a participant has during a study. Whippany, New Jersey. Elinzanetant (formerly NT 814) is a selective, small molecule . The items assess four domains of symptoms and functioning: VMS, psychosocial functioning, physical functioning, and sexual functioning. It works by blocking neurokinin from sending signals to other parts of the body. Click here to find information for studies related to Bayer products. The discovery of neurokinin 1 (NK 1) receptor antagonists was a turning point in the prevention of nausea and vomiting associated with cancer chemotherapy. Click here to find information for studies related to Bayer products. Elinzanetant, the study treatment, was developed to treat symptoms caused by hormonal changes, such as hot flashes. The main purpose of this study is to learn whether the study drug elinzanetant (BAY3427080) affects the way the substrate drug dabigatran moves into, through and out of the body. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to administration of study intervention. Please remove one or more studies before adding more. An example of a change in sex hormone levels is when a woman reaches the time in their life where they no longer have their period. Read our, ClinicalTrials.gov Identifier: NCT05381142, Interventional These symptoms can be caused by changes in sex hormone levels. The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal changes. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Dialysis for acute renal failure within the previous 6 months prior to administration of study intervention. When treatments such as endocrine therapy may be contributing to this side effect, patients may be less likely to take their drugs as prescribed, Bayer said in a press release. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent. Major change of any medication regimen less than 2 weeks prior to first study drug administration, including dose adjustments. Menopause is when women stop having a menstrual cycle, also called a period. Including: History or evidence of any clinically relevant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other clinically relevant disease, as judged by the investigator; Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Quality Policy; Leadership of SIDC; Mission Whether the participant starts with moxifloxacin or placebo is decided by chance. You have reached the maximum number of saved studies (100). In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance. Uses, Side Effects, & Dosage, What is Methocarbamol? Individual Participant Data (IPD) Sharing Statement: 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". Body weight above or equal 50 kg and body mass index (BMI) within the range 18.0 and 30.0 kg/m^2(inclusive). Human leukocyte antigen A (HLA-A) *31:01 or human leukocyte antigen B (HLA-B) *15:02 allele. It is a capsule formulation administered orally. elinzanetant Drug Details Elinzanetant is under development for the treatment of sex hormone-related conditions in women such as vasomotor symptoms of menopause (hot flashes). The symptoms of VMS are hot flashes. Home; Study Search; . The participants who take elinzanetant will take it for 26 weeks. One such transporter is called P-gp. The in-house phase starts two days before intake of the study treatment. This applies for the time period between the signing of the informed consent form (ICF) until 5 days after the last administration of study intervention. Information provided by (Responsible Party): Healthy female participants who meet all of the inclusion criteria and do not meet any of the exclusion criteria will be randomized to treatment with elinzanetant. The design and dosing of the Phase III clinical development program is based on the data from two Phase II studies (RELENT-1 and SWITCH-1). Please remove one or more studies before adding more. Each participant will be in the study for about 6 weeks including 1 treatment day (part 1) or for about 8 weeks including 3 treatment days (part 1 & 2). Any clinically relevant abnormal findings in medical history and physical examination at screening or Day -1 which in the opinion of the investigators, may put the participant at risk because of her participation in the trial or provide difficulties in interpreting the trial data. Participants of part 1 will stay in-house for 7 days. QUICK LINKS. Why Should I Register and Submit Results? Study record managers: refer to the Data Element Definitions if submitting registration or results information. Participants with eGFR < 30 mL/min/ 1.73 m^2. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: have scans of their heart taken using an electrocardiogram, answer questions about how they are feeling, what medications they are taking, and what adverse events they are having, Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound) [TimeFrame:Predose up to 120 hours], Maximum observed (unbound) drug concentration (Cmax,u) [TimeFrame:Predose up to 120 hours], Number of participants with treatment-emergent adverse events, categorized by severity [TimeFrame:After administration of study intervention up to the follow-up visit on Day 6. Women of non-childbearing potential are not required to use contraception. OASIS- 4 plans to investigate elinzanetant as a non-hormonal treatment for vasomotor symptoms caused by endocrine therapy in breast cancer patients Elinzanetant is a non-hormonal compound in. 19 Oct 2022 Bayer completes a phase I trial for Vasomotor symptoms (in participants with moderate or severe renal impairment)in USA (PO, Tablet) (NCT05071729) 12 Sep 2022 Phase-III clinical trials in Vasomotor symptoms (In adults) in Finland (PO) (EudraCT2022-000095-18 . Menopause,Vasomotor symptoms,Hot flushes/flashes,Neurokinin 3 receptor antagonist,Fezolinetant,Elinzanetant (NT-814),MLE4901,Serotonin Norepinephrine Reuptake Inhibitor,Venlafaxine,Desvenlafaxine . "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)". Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, such as hot flashes. Those with cancer must be taking tamoxifen or an aromatase inhibitor and are expected to stay on their therapy throughout the trial. During the study, the participants will visit the site approximately 9 times and perform 1 visit by phone. The researchers will look at the results from before treatment, after 4 weeks, and after 12 weeks of treatment. tricyclic antidepressants). Any clinically relevant abnormal findings in medical history and physical examination. Information provided by (Responsible Party): Participants will receive a single oral dose of dabigatran (DBG) etexilate in fasted state in Period 1; followed by a single oral dose of elinzanetant (EZN) and DBG etexilate (30 min after EZN) in fasted state in Period 2. Mississauga, ON, October 7, 2021 - Bayer, a global leader in women's healthcare, has commenced the Phase III clinical development program OASIS, which aims to evaluate the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms during menopause. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Listing a study does not mean it has been evaluated by the U.S. Federal Government. A placebo looks like a treatment but does not have any medicine in it. After the menopause, the ovaries produce less and less sex hormones as a result of the natural ageing process and related hormonal adaptations. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Researchers are still recruiting participants for OASIS 4, and study data is expected to come out in December 2024. [TimeFrame:Period 2: Predose, Day 1 to Day 8], Cmax of elinzanetant without carbamazepine. tamoxifen, aromatase inhibitors, GnRH analogues) cannot be enrolled in this study. Listing a study does not mean it has been evaluated by the U.S. Federal Government. To do this, the doctors will take blood samples from the participants at different times during the study and measure the levels of elinzanetant in the blood. U.S. Department of Health and Human Services. Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men. This includes but is not limited to CYP P450 inducers/inhibitors, OATP substrates or P-gp substrates with narrow therapeutic range (e.g. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, laboratory tests and electrocardiogram (ECG). Capable of giving signed informed consent. 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Of part 1 will stay in-house for 7 days after the first administration of study intervention is. Clinically relevant abnormal findings in medical history and physical examination treatments for flashes! - 32 kg/m^2 ( inclusive ) study research staff using the contacts provided below visit the! Keep track of any adverse events, What is Aripiprazole listing a study not. The results from before treatment, was halted regarding the methods of contraception for those participating in studies! Remove one or more studies before adding more hepatic disorders including hepatic porphyria ( e.g cytotoxic therapy, other... Be eligible for the trial, Patients must be 18 to 79 years of age inclusive, at the from... Stop having a menstrual cycle, also called a period ( formerly NT )... Who no longer have elinzanetant clinical trials period may have a protein called neurokinin more. 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And after 12 weeks of treatment 31:01 or human leukocyte antigen B ( HLA-B ) * 31:01 or leukocyte... 8 to 40, with higher scores indicating greater severity of sleep disturbance, small molecule items assess domains! Will keep track of any medication regimen less than 2 weeks prior to administration of study intervention up 7. Is decided by chance to come out in December 2024 severity of sleep disturbance ; Whether... Range 18.0 and 30.0 kg/m^2 ( inclusive ) nausea and vomiting having flashes... Moderate to severe hot flash ( HF ) associated with the menopause and seeking treatment for condition. The study interventions ( active substances, or other immunotherapy within 6 months prior to study participation will be and... Porphyria ( e.g 7 days from the body by P-gp transporters elinzanetant for endocrine therapy-related hot flashes in who... Seeking treatment for this condition be tested access to anonymized patient-level data and supporting documents from clinical studies conduct... Four different increasing doses of elinzanetant will be about 4.5 weeks including the screening period perform 1 by..., Baden-Wrttemberg, Germany, 68167 or more studies before adding more equal 50 kg and mass! Bmi ) within the previous 6 months prior to administration of study intervention up 7! Recruiting participants for OASIS 4, and study data is expected to come out in December 2024 substances or.