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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004908-33 | 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 Hot Flash Daily Diary [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 4, Days 22-28 were used (Day 1 corresponds to start of treatment). Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week | 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, Days 78-84 were used (Day 1 corresponds to start of treatment). Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week | 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. | From baseline to Week 4 |
| Mean Change in Severity of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 1 (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 (Day 1 corresponds to start of treatment). Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week |
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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 these women 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 |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham, AL | Birmingham | Alabama | 35205 | United States | ||
| Central Research Associates | Birmingham, AL |
| 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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A total of 1535 participants were screened; 1139 participants were not randomized. Most common reason for not being randomized was not meeting the eligibility criteria (1087 participants). 396 participants were randomized to treatment. A total of 197 participants were randomized to placebo - elinzanetant 120 mg arm and 199 participants to elinzanetant 120 mg arm.
Study was conducted at 89 study centers in 8 countries, between 27-Aug-2021 (first participant first visit) and 27-Nov-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 |
|
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 |
| From baseline to Week 1 |
| Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time. | 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 was not available for more than 2 days within a week, the value for that particular week was 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 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 participant 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. Each score ranged from 1-8, higher scores indicated greater bother. | From baseline to Week 12 |
| Mean Beck Depression Inventory (BDI-II) Total Score From Baseline to Week 12. | The BDI-II was a 21-item questionnaire assessed the intensity of depressive symptoms 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 mild depression, 20 - 28 indicating moderate and 29 - 63 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 was a 21-item questionnaire assessing the intensity of depressive symptoms 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 mild depression, 20 - 28 indicating moderate and 29 - 63 severe depression (higher score = greater depression). | From baseline to Week 26 |
| Birmingham |
| Alabama |
| 35205 |
| United States |
| Mesa Obstetricians and Gynecologists | Research Department | Mesa | Arizona | 85206 | United States |
| MomDoc Women's Health Research | Scottsdale, AZ | Scottsdale | Arizona | 85251 | United States |
| Noble Clinical Research | Tucson, AZ | Tucson | Arizona | 85704 | United States |
| Del Sol Research | Women Health studies | Tucson | Arizona | 85715 | United States |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72205 | United States |
| Alliance Research Institute | Bell Gardens, CA | Bell Gardens | California | 90201 | United States |
| Diagnamics | Encinitas, CA | Encinitas | California | 92024 | United States |
| Om Research LLC | Lancaster, CA | Lancaster | California | 93534 | United States |
| Northern California Research | Sacramento | Sacramento | California | 95821 | United States |
| IntimMedicine | Washington, DC | Washington D.C. | District of Columbia | 20036 | United States |
| AMR - Fort Myers, FL | Fort Myers | Florida | 33912 | United States |
| Suncoast Clinical Research Inc | Pinellas | Palm Harbor | Florida | 34684 | United States |
| Physician Care Clinical Research LLC | Sarasota, FL | Sarasota | Florida | 34239 | United States |
| Medisense Inc. | Atlanta, GA | Atlanta | Georgia | 30363 | United States |
| Paramount Research Solutions | College Park Location | College Park | Georgia | 30349 | United States |
| Soapstone Center for Clinical Research, Inc. | Decatur, GA | Decatur | Georgia | 30033-3500 | United States |
| Drug Studies America | Marietta | Georgia | 30060 | United States |
| M3 Wake Research Atlanta | Sandy Springs | Georgia | 30126 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Investigators Research Group, LLC | Brownsburg | Indiana | 46112 | United States |
| The Iowa Clinic - Ankeny | Ankeny | Iowa | 50023 | United States |
| Southern Clinical Research Associates | Metairie, LA | Metairie | Louisiana | 70001 | United States |
| Continental Clinical Solutions | Towson, MD | Towson | Maryland | 21204 | United States |
| Revive Research Institute, Inc. - Women's Health | Dearborn Heights | Michigan | 48127 | United States |
| Valley OBGYN | Saginaw | Michigan | 48602 | United States |
| Women's Clinic of Lincoln, P.C. | Lincoln, NE | Lincoln | Nebraska | 68510 | United States |
| Jubilee Clinical Research Inc | Las Vegas, NV | Las Vegas | Nevada | 89106 | United States |
| Affiliated Clinical Research, Inc. | Las Vegas, NV | Las Vegas | Nevada | 89113 | United States |
| M3 Wake Research - Clinical Research Center of Nevada | Las Vegas | Nevada | 89123 | United States |
| The Center for Womens Health & Wellness, LLC | Lawrenceville, NJ | Lawrenceville | New Jersey | 08648 | United States |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| Velocity Clinical Research - Albuquerque | Albuquerque | New Mexico | 87107 | United States |
| Bosque Women's Care | Albuquerque, NM | Albuquerque | New Mexico | 87109 | United States |
| Circuit Clinical | OB GYN Associates of WNY | West Seneca | New York | 14224 | United States |
| OnSite Clinical Solutions - Charlotte | Charlotte | North Carolina | 28277 | United States |
| M3 Wake Research | Raleigh, NC | Raleigh | North Carolina | 27612 | United States |
| Unified Women's Clinical Research | Lyndhurst Clinical Research, Winston-Salem, NC | Winston-Salem | North Carolina | 27103 | United States |
| Axia Women's Health - Anderson Township | Cincinnati | Ohio | 45242 | United States |
| Centricity Research - Women's Health - Dublin, OH | Dublin | Ohio | 43016 | United States |
| HWC Women's Research Center | Englewood, OH | Englewood | Ohio | 45322 | United States |
| Hilltop Obstetrics & Gynecolofy | Franklin | Ohio | 45005 | United States |
| Women's Care Research Institute/Marion OBGYN, Inc. | Marion | Ohio | 43302 | United States |
| University Hospitals | UH Cleveland Medical Center - MacDonald Clinical Trials Unit | Mayfield Heights | Ohio | 44124 | United States |
| Clinical Research Philadelphia | Philadelphia, PA | Philadelphia | Pennsylvania | 19114 | United States |
| MUSC Women's Health - Cannon St. | Charleston | South Carolina | 29425 | United States |
| Venus Gynecology, LLC | Myrtle Beach, SC | Myrtle Beach | South Carolina | 29572 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Chattanooga Medical Research, LLC. | Chattanooga, TN | Chattanooga | Tennessee | 37404 | United States |
| Elligo Health Research | Women Partners in Health PLLC | Austin | Texas | 78705 | United States |
| Cedar Health Research, LLC. | DFW-East Clinical Site | Dallas | Texas | 75251 | United States |
| Maximos Ob/Gyn | League City | Texas | 77573 | United States |
| Northeast Clinical Research of San Antonio, LLC | San Antonio | Texas | 78233 | United States |
| Seattle Women's | Seattle, WA | Seattle | Washington | 98105 | United States |
| Medical University of Graz | Division of Gynecology and Obstetrics | Graz | Styria | 8036 | Austria |
| Medizinische Universitat Innsbruck | Klinik fur Gyn Endokrinologie und Reproduktionsmedizin | Innsbruck | Tyrol | 6020 | Austria |
| Kepler Campus IV | Gyn, Gburtshilfe & gyn. Endokrinologie | Linz | Upper Austria | 4020 | Austria |
| AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie | Vienna | 1090 | Austria |
| Medizinische Universitat Wien | Universitatsklinik fur Frauenheilkunde Klinische Abteilung fur Gynakologische Endokrinologie | Vienna | 1090 | Austria |
| Gynekologie MEDA s.r.o. | Brno | 602 00 | Czechia |
| G-Centrum Olomouc s.r.o. Dr. Skrivanek | České Budějovice | 370 01 | Czechia |
| GYN-MIKA s.r.o. | České Budějovice | 370 01 | Czechia |
| Gynekologie Cheb s.r.o. | České Budějovice | 370 01 | Czechia |
| MUDr. Stepan s.r.o. | České Budějovice | 370 01 | Czechia |
| GYN-F s.r.o. | Hradec Králové | 500 03 | Czechia |
| Kestr-gyn s.r.o. | Náchod | 547 01 | Czechia |
| PT-MEDICA s.r.o. | Prachatice | 383 01 | Czechia |
| GYNERA | Prague | 156 00 | Czechia |
| Gynekologie Studentsky dum s.r.o. | Prague | 160 00 | Czechia |
| ARETAIEION University Hospital | Athens | 11528 | Greece |
| University General Hospital of Athens "ATTIKON" | Chaïdári | 12462 | Greece |
| University General Hospital of Heraklion - Department of Paediatrics | Heraklion | 711 10 | Greece |
| Univ. General Hospital of Ioannina - Department of Paediatrics, Nephrology Unit | Ioannina | 45500 | Greece |
| University General Hospital of Patras | Univ Obs & Gynae Cli | Pátrai | 26504 | Greece |
| Hippokration General Hospital of Thessaloniki | Thessaloniki | 54642 | Greece |
| General Hospital of Thessaloniki Papageorgiou | Thessaloniki | 56403 | Greece |
| TritonLife Medical Center, XIII.kerulet | Budapest | 1134 | Hungary |
| NAP-MED Egeszsegugyi Szolgaltato Kft | Debrecen | 4028 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Komaromi Selye Janos Korhaz | Komárom | 2900 | Hungary |
| SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont | Szeged | 6720 | Hungary |
| Rub-Int Noi Egeszsegcentrum | Székesfehérvár | 8000 | Hungary |
| HaEmek Medical Center | Internal Medicine C Department - Research Unit | Afula | 1834111 | Israel |
| Mayanei HaYeshua Medical Center | Bnei Brak | 5154475 | Israel |
| Hillel Yaffe Medical Center | Hadera | 3810101 | Israel |
| Hadassah Hebrew University Hospital Ein Kerem | Jerusalem | 9112001 | Israel |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Health Corporation of Galilee Medical Center | Nahariya | 2210001 | Israel |
| University Hospital Of Ferrara - Ostetricia e Ginecologia | Ferrara | Emilia-Romagna | 44124 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Lombardy | 20122 | Italy |
| Ospedale San Raffaele s.r.l. - Ginecologia Ostetricia e Medicina della Riproduzione | Milan | Lombardy | 20132 | Italy |
| IRCCS Fondazione Policlinico San Matteo | Pavia | Lombardy | 27100 | Italy |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania | Catania | Sicily | 95123 | Italy |
| Careggi University Hospital | Florence | Tuscany | 50134 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | 56126 | Italy |
| Flevoziekenhuis | Almere Stad | MISSING | Netherlands |
| St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde | Nieuwegein | 3435 CM | Netherlands |
| Diakonessenhuis | Utrecht | 3582 KE | Netherlands |
| Related Info | View source |
| Study\_Synopsis-21651.docx attachment has been generated from the Study Synopsis template. Data may be populated from the following (as available) : Study (44.0), Protocol (0.4), Results(0.1) | 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 |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| 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 Hot Flash Daily Diary [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 4, Days 22-28 were used (Day 1 corresponds to start of treatment). Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week | Participants in full analysis set (FAS) with evaluable data. | 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, Days 78-84 were used (Day 1 corresponds to start of treatment). Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week | Participants in full analysis set (FAS) with evaluable data. | 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. | Participants in full analysis set (FAS) with evaluable data. | 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. | Participants in full analysis set (FAS) with evaluable data. | 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). | 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 (Day 1 corresponds to start of treatment). Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week | Participants in full analysis set (FAS) with evaluable data. | 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. | 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 was not available for more than 2 days within a week, the value for that particular week was set to missing. | Participants in full analysis set (FAS) with evaluable data. | 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. | Participants in full analysis set (FAS) with evaluable data. | Posted | Mean | Standard Deviation | T-score | From baseline to Week 12 |
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| Secondary | Mean 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 participant 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. Each score ranged from 1-8, higher scores indicated greater bother. | Participants in full analysis set (FAS) with evaluable data. | Posted | Mean | Standard Deviation | Scores on scale | From baseline to Week 12 |
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| Secondary | Mean Beck Depression Inventory (BDI-II) Total Score From Baseline to Week 12. | The BDI-II was a 21-item questionnaire assessed the intensity of depressive symptoms 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 mild depression, 20 - 28 indicating moderate and 29 - 63 severe depression (higher score = greater depression). | Participants in full analysis set (FAS) with evaluable data. | Posted | Mean | Standard Deviation | Scores on 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 was a 21-item questionnaire assessing the intensity of depressive symptoms 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 mild depression, 20 - 28 indicating moderate and 29 - 63 severe depression (higher score = greater depression). | Participants in full analysis set (FAS) with evaluable data. | Posted | Mean | Standard Deviation | Scores on 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 120 mg Week 1-12 | Subjects who received elinzanetant 120 mg during Weeks 1-12. Reported AEs for the exposure period Weeks 1-12 to elinzanetant. | 0 | 199 | 4 | 199 | 38 | 199 |
| EG001 | Placebo Week 1-12 | Subjects who received placebo during Weeks 1-12. Reported AEs for the exposure period to placebo. | 0 | 194 | 2 | 194 | 28 | 194 |
| EG002 | Elinzanetant 120 mg Week 13-26 | Subjects who received elinzanetant 120 mg during Weeks 1-12 and continued with elinzanetant 120 mg after Week 12. Reported AEs for the exposure period Weeks 13 - 26 to elinzanetant. | 0 | 171 | 0 | 171 | 6 | 171 |
| EG003 | Placebo - Elinzanetant 120 mg Week 13-26 | Subjects 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 | 168 | 9 | 168 | 9 | 168 |
| EG004 | Elinzanetant 120 mg Week 1-26 | Subjects 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 | 367 | 13 | 367 | 51 | 367 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA (26.0) | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (26.0) | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
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| Accident | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | 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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| Arthrodesis | Surgical and medical procedures | MedDRA (26.0) | Non-systematic Assessment |
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| Bunion operation | Surgical and medical procedures | MedDRA (26.0) | Non-systematic Assessment |
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| Mammoplasty | Surgical and medical procedures | 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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| Arthralgia | Musculoskeletal and connective tissue disorders | 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 | 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 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 |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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