check_circleStudy Completed
Vasomotor symptoms associated with menopause, Hot flashes
Bayer Identifier:
21810
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A study to learn more about how well elinzanetant works and how safe it is for the treatment of vasomotor symptoms (hot flashes) that are caused by hormonal changes over 52 weeks in women who have been through the menopause
Trial purpose
Researchers are looking for a better way to treat women who have hot flashes after they 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 is a treatment that looks like a medicine but does not have any medicine in it. To compare these study treatments, the participants will record information about their hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe they are. They will study the results from before treatment 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 will take the study treatments for 52 weeks.
During the study, the participants will visit their study site approximately 11 times and perform 2 visits by phone. Each participant will be in the study for approximately 62 weeks.
During the study, the participants will:
• record information about their hot flashes in an electronic diary
• answer questions about their symptoms
The doctors will:
• check the participants’ health
• take blood samples
• ask the participants questions about what medicines they are taking and if they are having adverse events
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
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 is a treatment that looks like a medicine but does not have any medicine in it. To compare these study treatments, the participants will record information about their hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe they are. They will study the results from before treatment 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 will take the study treatments for 52 weeks.
During the study, the participants will visit their study site approximately 11 times and perform 2 visits by phone. Each participant will be in the study for approximately 62 weeks.
During the study, the participants will:
• record information about their hot flashes in an electronic diary
• answer questions about their symptoms
The doctors will:
• check the participants’ health
• take blood samples
• ask the participants questions about what medicines they are taking and if they are having adverse events
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Key Participants Requirements
Sex
FemaleAge
40 - 65 YearsTrial summary
Enrollment Goal
628Trial Dates
August 2021 - February 2024Phase
Phase 3Could I Receive a placebo
YesProducts
Elinzanetant (BAY3427080)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Queen Charlottes & Chelseas Hospital | London, W12 0NN, United Kingdom |
Completed | Liverpool Womens Hospital | Liverpool, L8 7SS, United Kingdom |
Completed | Glasgow Royal Infirmary | Haematology | Glasgow, G4 0SF, United Kingdom |
Completed | Southern Clinical Research Associates LLC | Metairie, 70001, United States |
Completed | Advances in Health, Inc. | Houston, 77030, United States |
Completed | Suncoast Clinical Research Center, Inc. | New Port Richey, 34652, United States |
Completed | Paramount Research Solutions-College Park | College Park, 30349, United States |
Completed | Hospital de la Santa Creu i Sant Pau | Gynecology Department | Barcelona, 8041, Spain |
Withdrawn | Hospital Clínico Universitario San Carlos | Madrid, 28040, Spain |
Completed | Hospital Sanitas La Zarzuela | Aravaca, 28023, Spain |
Completed | H Univ. 12 de Octubre | Ginecología y Obstetricia | Madrid, 28041, Spain |
Completed | Sanos Clinic - Nordjylland | Gandrup, 9362, Denmark |
Completed | Sanos Clinic - Syddanmark | Vejle, 7100, Denmark |
Completed | Sanos Clinic - Herlev | Herlev, 2730, Denmark |
Completed | MC Asklepii OOD | Dupnitza, 2600, Bulgaria |
Completed | Medical Center Panaceya | Sofia, 1606, Bulgaria |
Completed | MHAT Avis Medika | Pleven, 5800, Bulgaria |
Completed | MHAT Niamed | Stara Zagora, 6000, Bulgaria |
Completed | Multiprofile Hospital for Activ Treatment Plovdiv | Plovdiv, 4000, Bulgaria |
Completed | SHOGAT Prof Dimitar Stamatov | Varna, 9000, Bulgaria |
Completed | MHAT Samokov | Samokov, 2000, Bulgaria |
Completed | DCC Aleksandrovska | Sofia, 1431, Bulgaria |
Completed | Helix Biomedics, LLC | Boynton Beach, 33435, United States |
Completed | University of Florida College of Medicine | Jacksonville, 32207, United States |
Completed | Tidewater Physicians for Women | Norfolk, 23502, United States |
Completed | Office of Dr. Edmond Pack | Las Vegas, 89113, United States |
Completed | Physician Care Clinical Research | Sarasota, 34239, United States |
Completed | Seattle Clinical Research Center | Seattle, 98105, United States |
Completed | Marvel Clinical Research, LLC | Huntington Beach, 92647, United States |
Completed | Las Vegas Clinical Trials, LLC | North Las Vegas, 89030, United States |
Completed | Suncoast Clinical Research | Palm Harbor, 34684, United States |
Completed | Wake Research, Inc. | Raleigh, 27612, United States |
Completed | Mesa Obstetricians and Gynecologists | Mesa, 85206, United States |
Completed | Venus Gynecology, LLC former Magnolia OB/GYN Research Center | Myrtle Beach, 29572, United States |
Completed | Clinical Research of Philadelphia, LLC | Philadelphia, 19114, United States |
Withdrawn | Conquest Clinical Research, LLC | Santa Ana, 92701, United States |
Completed | Women's Health Texas | Katy, 77450, United States |
Completed | Office of Dr. James A. Simon, MD | Washington, 20036, United States |
Completed | Women's Health Texas | Katy, 77450, United States |
Completed | David I Lubetkin, MD, LLC | Boca Raton, 33486, United States |
Completed | Mobile Ob-Gyn, PC | Mobile, 36608-6703, United States |
Completed | Eastern Virginia Medical School | OB/GYN Clinical Research Center | Norfolk, 23507, United States |
Completed | UT Health Women’s Research Center at Memorial City | Houston, 77024, United States |
Completed | Columbus OB-GYN/Radiant Research | Columbus, 43213, United States |
Completed | Empire Clinical Research | Pomona, 91767, United States |
Completed | Coastal Connecticut Research, LLC | New London, 06320, United States |
Completed | Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob | Baltimore, 21287, United States |
Completed | Gabinet Ginekologiczny Janusz Tomaszewski | Bialystok, 15-244, Poland |
Completed | Vita Longa Sp. z o.o. | Katowice, 40-748, Poland |
Completed | Centrum Medyczne Angelius Provita | Katowice, 40-611, Poland |
Completed | Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin, 71-434, Poland |
Completed | CLINICAL MEDICAL RESEARCH Sp. z o. o. | Katowice, 40-156, Poland |
Completed | Centrum Badawcze Wspolczesnej Terapii | Warszawa, 02-679, Poland |
Completed | Hospital Clinico Universitario | Gynecology and Obstetrics Department | Valencia, 46010, Spain |
Completed | Instituto Palacios de Salud y Medicina de la Mujer | Madrid, 28009, Spain |
Completed | MAC Research Centre Blackpool | Blackpool, United Kingdom |
Completed | AMR Las Vegas | Las Vegas, 89119, United States |
Completed | Ottawa Hospital-Riverside Campus | Ottawa, K1H 7W9, Canada |
Withdrawn | IWK Health Centre | Halifax, B3K 6R8, Canada |
Completed | Alpha Recherche Clinique LB9 | Quebec, G2J 0C4, Canada |
Completed | Viable Clinical Research Corporation | Scarborough, M1P 2T7, Canada |
Completed | Manna Research (Ottawa) | Nepean, K2J 4A7, Canada |
Completed | Manna Research (Burlington North) | Burlington, L7M 4Y1, Canada |
Completed | Manna Research (Montreal) | Pointe-Claire, H9R 4S3, Canada |
Completed | Manna Research (Quebec) | Levis, G6W 0M5, Canada |
Completed | UZ Gent | GENT, 9000, Belgium |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | CHR de la Citadelle - Department of Gynaecology & Obstetrics | LIEGE, 4000, Belgium |
Completed | CHU Saint-Pierre/UMC Sint-Pieter | BRUXELLES - BRUSSEL, 1000, Belgium |
Completed | Femicare vzw | Tienen, 3300, Belgium |
Completed | Lääkärikeskus Gyneko | Oulu, 90100, Finland |
Completed | HUS / Naistenklinikka | Helsinki, 00029, Finland |
Withdrawn | Auraklinikka | Turku, 20100, Finland |
Completed | Mehiläinen Kuopio | Kuopio, 70100, Finland |
Completed | Terveystalo Tampere | Tampere, 33100, Finland |
Completed | H Univ. Virgen Rocío | Ginecología | Sevilla, 41013, Spain |
Completed | Pihlajalinna Lääkärikeskus Oy, Savo-Karjala | Joensuu, 80100, Finland |
Completed | National Institute of Clinical Research - Garden Grove | Garden Grove, 92844, United States |
Completed | Southern Clinical Research, LLC | Zachary, 70791, United States |
Withdrawn | Privia Medical Group North | Rowlett, 75088, United States |
Completed | Investigators Research Group, LLC | Brownsburg, 46112, United States |
Completed | Boeson Research - Missoula | Missoula, 59804, United States |
Completed | MHAT for Women's Health - Nadezhda OOD | Sofia, 1330, Bulgaria |
Completed | Spec. Hospital for Active Treatment of Oncological Diseases | Sofia, 1233, Bulgaria |
Completed | Maximos Ob/Gyn | League City, 77573, United States |
Completed | MAC Research Centre - Manchester | Manchester, United Kingdom |
Completed | Boeson Research - Great Falls OBGYN | Great Falls, 59405, United States |
Withdrawn | Wasatch Clinical Research, LLC | Salt Lake City, 84107, United States |
Completed | HWC Women’s Research Center | Englewood, 45322, United States |
Not yet recruiting | Spec.Hospital for obstetrics and gynecology Selena OOD | Plovdiv, 4002, Bulgaria |
Primary Outcome
- Mean change in frequency of moderate to severe hot flashes (HFs) from baseline to Week 12 (assessed by hot flash daily diary [HFDD])date_rangeTime Frame:Baseline to Week 12
Secondary Outcome
- Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score over time.The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Four of the items are scored reversely. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.date_rangeTime Frame:Baseline to Week 56
- Mean change in menopause specific quality of life scale (MENQOL) total score over timeThe MENQOL questionnaire is 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 assess four domains of symptoms and functioning: Vasomotor functioning, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicates if they have experienced the symptom (yes/no). If they select yes, they rate 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 are calculated. Each score ranges from 1-8, higher scores indicate greater bother.date_rangeTime Frame:Baseline to Week 56
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2