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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004855-34 | EudraCT Number |
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Researchers are looking for a better way to treat women who have hot flashes after women have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life.
The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. 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. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people.
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. A placebo looks like a treatment but does not have any medicine in it. To compare these study treatments, the doctors will ask the participants to record information about the participants' hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe the hot flashes are. The researchers will look at the results from before treatment, after 4 weeks, and after 12 weeks of treatment.
The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants who take elinzanetant will take it for 26 weeks. The participants who take the placebo will take it for 12 weeks and then take elinzanetant for the next 14 weeks.
During the study, the participants will visit the site approximately 9 times and perform 1 visit by phone. Each participant will be in the study for approximately 36 weeks. The treatment duration will be 26 weeks.
During the study, the participants will:
The doctors will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elinzanetant (BAY3427080) | Experimental | Participants will receive 120 mg elinzanetant orally once daily for 26 weeks. |
|
| Placebo + elinzanetant | Placebo Comparator | Participants will receive matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elinzanetant (BAY3427080) | Drug | 120 mg elinzanetant orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD) | Participants' assessments of HF were recorded electronically twice daily using the sponsor developed Hot Flash Daily Diary (HFDD). The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. The HFDD items assessed the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF was defined as a "sensation of heat without sweating", moderate HF was defined as a "sensation of heat with sweating, but able to continue activity", and severe HF was defined as a "sensation of heat with sweating, causing cessation (stopping) of activity". The frequency of moderate to severe HF for each week during the treatment period was calculated using the available data during that particular week. Specifically, for Week 4, Day 22-28 were used (Day 1 corresponds to start of treatment). | From baseline to Week 4 |
| Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD) | The frequency of moderate to severe HF for each week during the treatment period was calculated using the available data during that particular week. Specifically, for Week 12, Day 78-84 were used (Day 1 corresponds to start of treatment). | From baseline to Week 12 |
| Mean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD) | In the HFDD, hot flash (HF) severity is scored as 1=mild, 2=moderate, and 3=severe; a decrease indicates improvement. The diary records the number of mild, moderate, and severe HFs during day and night. Mild HFs are a "sensation of heat without sweating"; moderate are "heat with sweating but able to continue activity"; severe are "heat with sweating that stops activity." Baseline mean daily severity is calculated as: (2×moderateHFs+3×severeHFs)÷(totalmoderate+severeHFs).(2 × moderate HFs + 3 × severe HFs) ÷ (total moderate + severe HFs).(2×moderateHFs+3×severeHFs)÷(totalmoderate+severeHFs). If none occur, severity=0. Weekly severity during treatment is based on available days (Week 4: Days 22-28; Week 12: Days 78-84; Day 1=start of treatment), averaging the mean daily severity for that week. If more than 2 days are missing, the weekly value is set to missing |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 1 (Assessed by HFDD) | Participants' assessments of HF were recorded electronically twice daily using the sponsor developed HFDD. The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. | From baseline to Week 1 |
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Inclusion Criteria:
Postmenopausal, defined as:
Moderate to severe hot flash (HF) associated with the menopause and seeking treatment for this condition.
Participant has completed Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks preceding baseline visit, and participant has recorded at least 50 moderate or severe HF (including night-time HF) over the last 7 days that the HFDD was completed (assessed at the Baseline Visit).
Exclusion Criteria:
Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on ECG evaluation.
Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms (VMS) such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome.
Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors). Women receiving adjuvant endocrine therapy (e.g. tamoxifen, aromatase inhibitors, GnRH analogues) cannot be enrolled in this study.
Uncontrolled or treatment-resistant hypertension. Women with mild hypertension can be included in the study if they are medically cleared prior to study participation.
Untreated hyperthyroidism or hypothyroidism.
Any unexplained post-menopausal uterine bleeding.
Clinically relevant abnormal findings on mammogram.
Abnormal liver parameters.
Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accel Research Sites | Cahaba Medical Care - Birmingham, AL | Birmingham | Alabama | 35218 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39172446 | Derived | Pinkerton JV, Simon JA, Joffe H, Maki PM, Nappi RE, Panay N, Soares CN, Thurston RC, Caetano C, Haberland C, Haseli Mashhadi N, Krahn U, Mellinger U, Parke S, Seitz C, Zuurman L. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials. JAMA. 2024 Aug 22;332(16):1343-54. doi: 10.1001/jama.2024.14618. Online ahead of print. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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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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A total of 1483 participants were screened, of whom 1083 participants were screen failures. Most common reason for screen failure was not meeting the eligibility criteria (1044 participants). 400 of the screened participants were randomized to treatment and 324 participants completed the study.
Study was conducted at 95 study centers in 10 countries worldwide, between 29-Oct-2021 (first participant first visit) and 10-Oct-2023 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Elinzanetant 120 mg | Participants received elinzanetant 120 mg orally once daily for 26 weeks |
| FG001 | Placebo - Elinzanetant 120 mg | Participants received placebo for 12 weeks, followed by elinzanetant 120 mg orally once daily for 14 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2022 | Nov 4, 2025 |
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| Placebo | Drug | Matching placebo orally once daily |
|
| From baseline to Week 4 |
| Mean Change in Severity of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD) | In the HFDD, hot flash (HF) severity is categorized as 1=mild, 2=moderate, 3=severe; thus, a decrease indicates improvement. The HFDD records the number of mild, moderate, and severe HFs during day and night. Mild HFs are a "sensation of heat without sweating"; moderate involve "heat with sweating but able to continue activity"; severe involve "heat with sweating that stops activity." Mean daily severity at baseline is calculated as: (2 × moderate HFs) + (3 × severe HFs)\] ÷ (total moderate + severe HFs). If none occur, severity is set to 0. Weekly severity during treatment is based on available days (Week 4: Days 22-28; Week 12: Days 78-84; Day 1=start of treatment), averaging mean daily severity across that week. If more than 2 days are missing, the week is set to missing. | From baseline to Week 12 |
| Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD) | The frequency of moderate to severe HF for each week during the treatment period was calculated using the available data during that particular week. Specifically, for Week 1 Days 2-8 were used instead of 1-7, because the intake started on Day 1 only before going to bed, for Week 4 Days 22-28 were used and for Week 12 Days 78-84 were used (Day 1 corresponds to start of treatment). These data were aggregated to a mean daily frequency as (total number of moderate to severe HF during that week) / (total number of available days with data during that week). In case data is not available for more than 2 days within a week, the value for that particular week was be set to missing. | From baseline to Week 30 |
| Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline to Week 12 | In controversy of what you have been proposing above here you are just explaining the PROMIS SD SF 8b scores, not the secondary endpoint which is the change in the T-scores from BL to week 12 The PROMIS Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) measures sleep disturbance over the past 7 days using 8 items assessing sleep quality, depth, restorative sleep, difficulty falling or staying asleep, and perceptions of sleep adequacy and satisfaction. Items use 5-point response options that vary by item (e.g., Not at all → Very much; Never → Always; Very poor → Very good). Item scores sum to a raw score of 8-40, which is converted to a T-score (mean 50, SD 10; range 28.9-76.5). Higher scores reflect greater sleep disturbance. PROMIS cut points classify T-scores of 55-59 as mild, 60-69 as moderate, and ≥70 as severe disturbance. | From baseline to Week 12 |
| Mean Change in Menopause-specific Quality of Life Scale (MENQOL) Total Score From Baseline to Week 12 | The MENQOL questionnaire was comprised of 29 items assessing the presence of menopausal symptoms and the impact of menopause on health-related quality of life over the past week. The items assessed four domains of symptoms and functioning: VMS, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participants indicated if they had experienced the symptom (yes/no). If participants selected yes, participants rated how bothered they were by the symptom using a six-point verbal descriptor scale, with response options ranging from 0 'not at all bothered' to 6 'extremely bothered'. Based on the individual responses, item scores, domain scores, and a total MENQOL score were calculated. The four domain scores were calculated as a mean of converted single item scores (range 1-8), and the mean of the four domain scores yielded the MENQOL total score. Higher scores indicated greater bother. | From baseline to Week 12 |
| Mean Change in Beck Depression Inventory (BDI-II) Total Score From Baseline to Week 12 | The BDI-II consisted of 21 items to assess the severity of depression over the past 2 weeks. Each item was a list of four statements arranged in increasing levels of severity about a particular symptom of depression. Items used a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options were tailored to the aspect of depression being measured in each item. A total score ranging from 0 to 63 was calculated with scores of 0-13 indicating mild minimal range, 14 - 19 indicating mild depression, 20 - 28 indicating moderate and 29 - 63 indicating severe depression (higher score = greater depression). | From baseline to Week 12 |
| Mean Change in BDI-II Total Score From Baseline to Week 26 | The BDI-II consisted of 21 items to assess the severity of depression over the past 2 weeks. Each item was a list of four statements arranged in increasing levels of severity about a particular symptom of depression. Items used a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options were tailored to the aspect of depression being measured in each item. A total score ranging from 0 to 63 was calculated with scores of 0-13 indicating mild minimal range, 14 - 19 indicating mild depression, 20 - 28 indicating moderate and 29 - 63 indicating severe depression (higher score = greater depression). | From baseline to Week 26 |
| Women's Health Alliance of Mobile |
| Mobile |
| Alabama |
| 36604 |
| United States |
| Onyx Clinical Research - Peoria | Peoria | Arizona | 85381 | United States |
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72204 | United States |
| National Institute of Clinical Research - Garden Grove | Garden Grove | California | 92844 | United States |
| Clinical Trials Research - Lincoln | Lincoln | California | 95648 | United States |
| Torrance Clinical Research Institute, Inc. | Lomita, CA | Lomita | California | 90717 | United States |
| Women's Health Care Research | San Diego, CA | San Diego | California | 92111 | United States |
| Advanced Women's Health Institute | Denver Office, Greenwood Village, CO | Greenwood Village | Colorado | 80111 | United States |
| Physicians' Research Options, LLC | Red Rocks OBGYN | Lakewood | Colorado | 80228 | United States |
| Helix Biomedics, LLC | Boynton Beach | Florida | 33435 | United States |
| Clinical Research of West Florida | Clearwater, FL | Clearwater | Florida | 33765 | United States |
| Sweet Hope Research Specialty, Inc. - Miami Lakes | Hialeah | Florida | 33016 | United States |
| Ocean Blue Medical Research Center, Inc | Miami Springs, FL | Miami Springs | Florida | 33166 | United States |
| Suncoast Clinical Research Inc. | Pasco | New Port Richey | Florida | 34652 | United States |
| Sensible Healthcare, LLC | Ocoee | Florida | 34761 | United States |
| Clinical Research of West Florida | Tampa, FL | Tampa | Florida | 33606 | United States |
| Fellows Research Alliance, Inc | Savannah, GA | Savannah | Georgia | 31406 | United States |
| Family Care Research | Boise, ID | Boise | Idaho | 83713 | United States |
| Leavitt Clinical Research | Idaho Falls, ID | Idaho Falls | Idaho | 83404 | United States |
| University of Chicago | Laboratory of Dr. Al-Hendy | Chicago | Illinois | 60637 | United States |
| AMR - Chicago | Oak Brook | Illinois | 60523 | United States |
| Clinical Trials Management | Northshore Office | Covington | Louisiana | 70433 | United States |
| Tandem Clinical Research | Marrero, LA | Marrero | Louisiana | 70072 | United States |
| Ob and Gyn Physicians MidAtlantic - SKYCRNG | Oxon Hill | Maryland | 20705 | United States |
| Genesis Clinical Research and Consulting, LLC | Fall River | Massachusetts | 02723 | United States |
| Saginaw Valley Medical Research Group, LLC | Saginaw, MI | Saginaw | Michigan | 48604 | United States |
| Metro Jackson OBGYN | Jackson, MS | Jackson | Mississippi | 39202 | United States |
| R. Garn Mabey Jr. M.D. Gynecology | Las Vegas | Nevada | 89128 | United States |
| Capital Health | Capital Health OBGYN Lawrenceville | Lawrenceville | New Jersey | 08648 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Eastern Carolina Women's Center | New Bern, NC | New Bern | North Carolina | 28562 | United States |
| Unified Women's Clinical Research | Raleigh, NC | Raleigh | North Carolina | 27607 | United States |
| OHSU Hospital - OB-GYN - Women's Health Research Unit | Portland | Oregon | 97239 | United States |
| UPMC Magee-Women's Hospital - Gynecology | Pittsburgh | Pennsylvania | 15213 | United States |
| Tribe clinical Research LLC | Greenville, SC | Greenville | South Carolina | 29607 | United States |
| Medical Research Center of Memphis | Memphis, TN | Memphis | Tennessee | 38120 | United States |
| Research Memphis Associates, LLC | Memphis, TN | Memphis | Tennessee | 38120 | United States |
| Austin Regional Clinic | ARC Kelly Lane | Austin | Texas | 78731 | United States |
| DiscoveResearch, Inc. | Bryan | Texas | 77802 | United States |
| South Texas Clinical Research | Corpus Christi | Texas | 78404 | United States |
| Sig Gyn Services (Dr. John A. Whitfield, MD) | Fort Worth, TX | Fort Worth | Texas | 76104-4145 | United States |
| Advances in Health, INC. | Houston, TX | Houston | Texas | 77030 | United States |
| UTHealth Womens Research Program | Memorial City | Houston | Texas | 77054 | United States |
| ClinRx Research, LLC | Plano | Texas | 75024 | United States |
| The Woman's Place - Midlife Health | Charlottesville | Virginia | 22903 | United States |
| Tidewater Clinical Research, Inc. | Norfolk | Virginia | 23456 | United States |
| Northwest Clinical Research Center | Bellevue, WA | Bellevue | Washington | 98007 | United States |
| Alta Clinical Research Inc | Edmonton, Canada | Edmonton | Alberta | T5A 4L8 | Canada |
| IWK Health Centre | Department of Obstetrics and Gynaecology | Halifax | Nova Scotia | B3K 6R8 | Canada |
| Ecogene 21 | Chicoutimi | Quebec | G7H 0S7 | Canada |
| GCP Research | Montreal, Canada | Montreal | Quebec | H1M 1B1 | Canada |
| Clinique Ovo | R&D Department | Montreal | Quebec | H4P 2S4 | Canada |
| Diex Recherche Sherbrooke Inc. | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Alpha Recherche Clinique | Val-Belair | Val-Bélair | Quebec | G3K 2P8 | Canada |
| Diex Recherche Victoriaville Inc. | Victoriaville | Quebec | G6P 6P6 | Canada |
| Diex Recherche Quebec Inc. | Québec | G1V 4T3 | Canada |
| Alpha Recherche Clinique | Lebourgneuf | Québec | G2J 0C4 | Canada |
| GynPorCentrum s.r.o. | Krnov | 794 01 | Czechia |
| MUDr. Martina Maresova Rosenbergova, gynekologie | Pilsen | 301 00 | Czechia |
| Gynekologie Studentsky dum s.r.o. | Prague | 160 00 | Czechia |
| GYNEVI s.r.o. | Rokycany | 337 01 | Czechia |
| Gynpraxetabor s.r.o. | Tábor | 390 03 | Czechia |
| Synexus Frankfurt Clinical Research Centre | Frankfurt am Main | Hesse | 60313 | Germany |
| Praxis Hr. Dr. S. Fiedler | Aachen | North Rhine-Westphalia | 52074 | Germany |
| Frauenärzte am Schloss Borbeck | Essen | North Rhine-Westphalia | 45355 | Germany |
| Medplus Nordrhein | Krefeld | North Rhine-Westphalia | 47799 | Germany |
| Synexus Leipzig Clinical Research Centre | Leipzig | Saxony | 04177 | Germany |
| Praxis f. Gynäkologie und Geburtshilfe | Bernburg | Saxony-Anhalt | 6406 | Germany |
| Frauenarztpraxis Dr. Inka Kiesche | Halle | Saxony-Anhalt | 06110 | Germany |
| Femme Frauenarztpraxis | Gera | Thuringia | 7545 | Germany |
| emovis GmbH | Berlin | 10629 | Germany |
| Synexus Berlin Clinical Research Centre | Berlin | 12627 | Germany |
| A.O.U. Policlinico Federico II Napoli | Naples | Campania | 80131 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Lazio | 00168 | Italy |
| Azienda Ospedaliera Ordine Mauriziano Di Torino | Turin | Piedmont | 10128 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia B | Verona | Veneto | 37126 | Italy |
| Kirkeparken Spesialistpraksis | Fredrikstad | 1605 | Norway |
| Medicus | Oslo, Norway | Oslo | 161 | Norway |
| Oslo University Hospital | Division of Obstetrics and Gynecology, Department of Research | Oslo | 450 | Norway |
| Medicus | Stavanger, Norway | Stavanger | 4005 | Norway |
| Medicus AS | Trondheim | 7014 | Norway |
| Gabinet Ginekologiczny Janusz Tomaszewski | Bialystok | 15-224 | Poland |
| CLINICAL MEDICAL RESEARCH Sp. z o. o. | Katowice | 40-156 | Poland |
| Centrum Medyczne Angelius Provita | Katowice | 40-611 | Poland |
| Vita Longa Sp. z o.o. | Katowice | 40-748 | Poland |
| Etyka Osrodek Badan Klinicznych | Olsztyn | 10-117 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71-500 | Poland |
| Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica | Loures | Lisbon District | 2674-514 | Portugal |
| Hospital Santa Maria | Centro de Investigacao Clinica | Missing | Lisbon District | 1649-035 | Portugal |
| Hospital Pedro Hispano | Clinical Research Center | Matosinhos Municipality | Porto District | 4464-513 | Portugal |
| Luz Saude | Hospital da Luz Setubal - Clinical Research Department | Setúbal | Setúbal District | 2900-722 | Portugal |
| Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Gynecology | Coimbra | 3000-075 | Portugal |
| Centro Hospitalar de Lisboa Ocidental | Clinical Research Department | Lisbon | 1449-005 | Portugal |
| Centro Hospitalar Universitario do Porto | Servico de Investigacao Clinica | Porto | 4050-651 | Portugal |
| RC Medical | Novosibirsk | 630091 | Russia |
| Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a Metoda | Bratislava | 851 07 | Slovakia |
| GYNARIN, s.r.o. | Fiľakovo | 986 01 | Slovakia |
| ULMUS, s r.o. | Hlohovec | 920 01 | Slovakia |
| Nemocnica AGEL Kocice-Saca a.s. | Kosice - Saca | 040 15 | Slovakia |
| GA Lucenec s.r.o | Lučenec | 984 01 | Slovakia |
| Virina sano, s.r.o. Gynekologicko porodnicka ambulancia | Veľký Krtíš | 990 01 | Slovakia |
| Kantonsspital Baden | Baden | Canton of Aargau | 5404 | Switzerland |
| Universitätsspital Basel | Basel | Canton of Basel-City | 4056 | Switzerland |
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Canton of Vaud | 1011 | Switzerland |
| Inselspital Universitätsspital Bern | Bern | 3010 | Switzerland |
| UniversitätsSpital Zürich | Zurich | 8091 | Switzerland |
| Ivano-Frankivsk Regional Perinatal Center | Ivano-Frankivsk | 76018 | Ukraine |
| Instr. of Pediatrics, Obstetrics & Gynecology | Kiev | 4050 | Ukraine |
| Center of innovative medical technologies of NAS of Ukraine | Kiev | 4053 | Ukraine |
| Medical Center LLC "Verum Expert Clinic" | Kyiv | 3039 | Ukraine |
| Medical Center Motor Sich | Zaporizhzhya | 69068 | Ukraine |
| CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional council | Zaporizhzhya | 69600 | Ukraine |
| Related Info | View source |
| Related Info | View source |
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Full analysis set (FAS) was analyzed. FAS: all randomized subjects were included. Subjects in the full analysis set were analyzed according to the randomized intervention (intention-to-treat).
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| ID | Title | Description |
|---|---|---|
| BG000 | Elinzanetant 120 mg | Participants received elinzanetant 120 mg orally once daily for 26 weeks |
| BG001 | Placebo - Elinzanetant 120 mg | Participants received placebo for 12 weeks, followed by elinzanetant 120 mg orally once daily for 14 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD) | Participants' assessments of HF were recorded electronically twice daily using the sponsor developed Hot Flash Daily Diary (HFDD). The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. The HFDD items assessed the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF was defined as a "sensation of heat without sweating", moderate HF was defined as a "sensation of heat with sweating, but able to continue activity", and severe HF was defined as a "sensation of heat with sweating, causing cessation (stopping) of activity". The frequency of moderate to severe HF for each week during the treatment period was calculated using the available data during that particular week. Specifically, for Week 4, Day 22-28 were used (Day 1 corresponds to start of treatment). | FAS | Posted | Mean | Standard Deviation | Hot Flashes per day | From baseline to Week 4 |
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| Primary | Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD) | The frequency of moderate to severe HF for each week during the treatment period was calculated using the available data during that particular week. Specifically, for Week 12, Day 78-84 were used (Day 1 corresponds to start of treatment). | FAS | Posted | Mean | Standard Deviation | Hot flashes per day | From baseline to Week 12 |
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| Primary | Mean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD) | In the HFDD, hot flash (HF) severity is scored as 1=mild, 2=moderate, and 3=severe; a decrease indicates improvement. The diary records the number of mild, moderate, and severe HFs during day and night. Mild HFs are a "sensation of heat without sweating"; moderate are "heat with sweating but able to continue activity"; severe are "heat with sweating that stops activity." Baseline mean daily severity is calculated as: (2×moderateHFs+3×severeHFs)÷(totalmoderate+severeHFs).(2 × moderate HFs + 3 × severe HFs) ÷ (total moderate + severe HFs).(2×moderateHFs+3×severeHFs)÷(totalmoderate+severeHFs). If none occur, severity=0. Weekly severity during treatment is based on available days (Week 4: Days 22-28; Week 12: Days 78-84; Day 1=start of treatment), averaging the mean daily severity for that week. If more than 2 days are missing, the weekly value is set to missing | FAS | Posted | Mean | Standard Deviation | Units on a scale | From baseline to Week 4 |
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| Primary | Mean Change in Severity of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD) | In the HFDD, hot flash (HF) severity is categorized as 1=mild, 2=moderate, 3=severe; thus, a decrease indicates improvement. The HFDD records the number of mild, moderate, and severe HFs during day and night. Mild HFs are a "sensation of heat without sweating"; moderate involve "heat with sweating but able to continue activity"; severe involve "heat with sweating that stops activity." Mean daily severity at baseline is calculated as: (2 × moderate HFs) + (3 × severe HFs)\] ÷ (total moderate + severe HFs). If none occur, severity is set to 0. Weekly severity during treatment is based on available days (Week 4: Days 22-28; Week 12: Days 78-84; Day 1=start of treatment), averaging mean daily severity across that week. If more than 2 days are missing, the week is set to missing. | FAS | Posted | Mean | Standard Deviation | Units on a scale | From baseline to Week 12 |
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| Secondary | Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 1 (Assessed by HFDD) | Participants' assessments of HF were recorded electronically twice daily using the sponsor developed HFDD. The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. | FAS | Posted | Mean | Standard Deviation | Hot flashes per day | From baseline to Week 1 |
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| Secondary | Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD) | The frequency of moderate to severe HF for each week during the treatment period was calculated using the available data during that particular week. Specifically, for Week 1 Days 2-8 were used instead of 1-7, because the intake started on Day 1 only before going to bed, for Week 4 Days 22-28 were used and for Week 12 Days 78-84 were used (Day 1 corresponds to start of treatment). These data were aggregated to a mean daily frequency as (total number of moderate to severe HF during that week) / (total number of available days with data during that week). In case data is not available for more than 2 days within a week, the value for that particular week was be set to missing. | FAS | Posted | Mean | Standard Deviation | Hot flashes per day | From baseline to Week 30 |
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| Secondary | Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline to Week 12 | In controversy of what you have been proposing above here you are just explaining the PROMIS SD SF 8b scores, not the secondary endpoint which is the change in the T-scores from BL to week 12 The PROMIS Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) measures sleep disturbance over the past 7 days using 8 items assessing sleep quality, depth, restorative sleep, difficulty falling or staying asleep, and perceptions of sleep adequacy and satisfaction. Items use 5-point response options that vary by item (e.g., Not at all → Very much; Never → Always; Very poor → Very good). Item scores sum to a raw score of 8-40, which is converted to a T-score (mean 50, SD 10; range 28.9-76.5). Higher scores reflect greater sleep disturbance. PROMIS cut points classify T-scores of 55-59 as mild, 60-69 as moderate, and ≥70 as severe disturbance. | FAS | Posted | Mean | Standard Deviation | Scores on a scale | From baseline to Week 12 |
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| Secondary | Mean Change in Menopause-specific Quality of Life Scale (MENQOL) Total Score From Baseline to Week 12 | The MENQOL questionnaire was comprised of 29 items assessing the presence of menopausal symptoms and the impact of menopause on health-related quality of life over the past week. The items assessed four domains of symptoms and functioning: VMS, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participants indicated if they had experienced the symptom (yes/no). If participants selected yes, participants rated how bothered they were by the symptom using a six-point verbal descriptor scale, with response options ranging from 0 'not at all bothered' to 6 'extremely bothered'. Based on the individual responses, item scores, domain scores, and a total MENQOL score were calculated. The four domain scores were calculated as a mean of converted single item scores (range 1-8), and the mean of the four domain scores yielded the MENQOL total score. Higher scores indicated greater bother. | FAS | Posted | Mean | Standard Deviation | Scores on a scale | From baseline to Week 12 |
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| Secondary | Mean Change in Beck Depression Inventory (BDI-II) Total Score From Baseline to Week 12 | The BDI-II consisted of 21 items to assess the severity of depression over the past 2 weeks. Each item was a list of four statements arranged in increasing levels of severity about a particular symptom of depression. Items used a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options were tailored to the aspect of depression being measured in each item. A total score ranging from 0 to 63 was calculated with scores of 0-13 indicating mild minimal range, 14 - 19 indicating mild depression, 20 - 28 indicating moderate and 29 - 63 indicating severe depression (higher score = greater depression). | FAS | Posted | Mean | Standard Deviation | Scores on a scale | From baseline to Week 12 |
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| Secondary | Mean Change in BDI-II Total Score From Baseline to Week 26 | The BDI-II consisted of 21 items to assess the severity of depression over the past 2 weeks. Each item was a list of four statements arranged in increasing levels of severity about a particular symptom of depression. Items used a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options were tailored to the aspect of depression being measured in each item. A total score ranging from 0 to 63 was calculated with scores of 0-13 indicating mild minimal range, 14 - 19 indicating mild depression, 20 - 28 indicating moderate and 29 - 63 indicating severe depression (higher score = greater depression). | FAS | Posted | Mean | Standard Deviation | Scores on a scale | From baseline to Week 26 |
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From the start of study medication up to 14 days after the last dose of medication, approximately 28 weeks. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, approximately 30 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elinzanetant 120mg Week 1-12 | Participants who received elinzanetant 120 mg during Weeks 1-12. Reported AEs for the exposure period Week 1-12 to elinzanetant. | 0 | 201 | 1 | 201 | 34 | 201 |
| EG001 | Placebo Week 1-12 | Participants who received placebo during Weeks 1-12. Reported AEs for the exposure period to placebo. | 0 | 199 | 1 | 199 | 25 | 199 |
| EG002 | Elinzanetant 120mg Week 13-26 | Participants who received elinzanetant 120 mg during Week 1-12 and continued with elinzanetant 120 mg after Week 12. Reported AEs for the exposure period Week 13 - 26 to elinzanetant. | 0 | 171 | 1 | 171 | 5 | 171 |
| EG003 | Placebo - Elinzanetant 120mg Week 13-26 | Participants who received placebo during Weeks 1-12 and switched to elinzanetant 120 mg after Week 12. Reported AEs for the exposure period to elinzanetant. | 0 | 180 | 3 | 180 | 8 | 180 |
| EG004 | Elinzanetant 120mg Week 1-26 | Participants who received elinzanetant 120 mg at any time during the study (including those who switched from placebo to elinzanetant 120 mg at Week 13). Reported AEs for the exposure period to elinzanetant for both treatment groups. | 0 | 381 | 5 | 381 | 45 | 381 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mechanical ileus | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
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| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
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| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
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| Device loosening | Product Issues | MedDRA (26.0) | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (26.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (26.0) | Non-systematic Assessment |
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| Depression rating scale score increased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
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PI will submit any proposed publications to the sponsor, who may advise PI within 30 days of any information that is confidential or requires protection and may request to remove confidential information or delay the publication for 60 days. For this multicenter study, PI will not, without the sponsor's consent, publish results until a multicenter publication is published; if that is not done within 12 months after study completion, PI may publish results in accordance with above provisions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer AG | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 23, 2023 | Nov 4, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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| More than one race |
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