Trial Condition(s):
Vasomotor symptoms associated with menopause, Hot Flashes
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 (OASIS-3)
Bayer Identifier:
21810
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Postmenopausal, defined as:
a. at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or
b. at least 6 months of spontaneous amenorrhea prior to signing of informed consent with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or
c. at least 6 months after hysterectomy at signing of informed consent with serum FSH levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or
d. surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to signing of informed consent.
- 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 is showing eligibility with respect to previous inclusion criterion during this time period.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. -- Treated hyperthyroidism with no abnormal increase of thyroid function laboratory parameters and no relevant clinical signs for > 6 months before signing of informed consent is acceptable. -- Treated hypothyroidism with normal thyroid function test results during screening and a stable (for ≥ 3 months before signing of informed consent) dose of replacement therapy is acceptable. - 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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Queen Charlottes & Chelseas Hospital London, United Kingdom, W12 0NN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liverpool Womens Hospital Liverpool, United Kingdom, L8 7SS | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Glasgow Royal Infirmary | Haematology Glasgow, United Kingdom, G4 0SF | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southern Clinical Research Associates LLC Metairie, United States, 70001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Advances in Health, Inc. Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Suncoast Clinical Research Center, Inc. New Port Richey, United States, 34652 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Paramount Research Solutions-College Park College Park, United States, 30349 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de la Santa Creu i Sant Pau | Gynecology Department Barcelona, Spain, 8041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Sanitas La Zarzuela Aravaca, Spain, 28023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations H Univ. 12 de Octubre | Ginecología y Obstetricia Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sanos Clinic - Nordjylland Gandrup, Denmark, 9362 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sanos Clinic - Syddanmark Vejle, Denmark, 7100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sanos Clinic - Herlev Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MC Asklepii OOD Dupnitza, Bulgaria, 2600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Center Panaceya Sofia, Bulgaria, 1606 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Avis Medika Pleven, Bulgaria, 5800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Niamed Stara Zagora, Bulgaria, 6000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiprofile Hospital for Activ Treatment Plovdiv Plovdiv, Bulgaria, 4000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SHOGAT Prof Dimitar Stamatov Varna, Bulgaria, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Samokov Samokov, Bulgaria, 2000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DCC Aleksandrovska Sofia, Bulgaria, 1431 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Helix Biomedics, LLC Boynton Beach, United States, 33435 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Florida College of Medicine Jacksonville, United States, 32207 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tidewater Physicians for Women Norfolk, United States, 23502 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Office of Dr. Edmond Pack Las Vegas, United States, 89113 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Physician Care Clinical Research Sarasota, United States, 34239 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seattle Clinical Research Center Seattle, United States, 98105 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Marvel Clinical Research, LLC Huntington Beach, United States, 92647 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Las Vegas Clinical Trials, LLC North Las Vegas, United States, 89030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Suncoast Clinical Research Palm Harbor, United States, 34684 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wake Research, Inc. Raleigh, United States, 27612 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mesa Obstetricians and Gynecologists Mesa, United States, 85206 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Venus Gynecology, LLC former Magnolia OB/GYN Research Center Myrtle Beach, United States, 29572 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Women's Health Texas Katy, United States, 77450 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Office of Dr. James A. Simon, MD Washington, United States, 20036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations David I Lubetkin, MD, LLC Boca Raton, United States, 33486 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mobile Ob-Gyn, PC Mobile, United States, 36608-6703 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Virginia Medical School | OB/GYN Clinical Research Center Norfolk, United States, 23507 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UT Health Women’s Research Center at Memorial City Houston, United States, 77024 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Columbus OB-GYN/Radiant Research Columbus, United States, 43213 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Empire Clinical Research Pomona, United States, 91767 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Coastal Connecticut Research, LLC New London, United States, 06320 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob Baltimore, United States, 21287 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gabinet Ginekologiczny Janusz Tomaszewski Bialystok, Poland, 15-244 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vita Longa Sp. z o.o. Katowice, Poland, 40-748 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum Medyczne Angelius Provita Katowice, Poland, 40-611 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin, Poland, 71-434 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice, Poland, 40-156 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum Badawcze Wspolczesnej Terapii Warszawa, Poland, 02-679 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clinico Universitario | Gynecology and Obstetrics Department Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Palacios de Salud y Medicina de la Mujer Madrid, Spain, 28009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MAC Research Centre Blackpool Blackpool, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AMR Las Vegas Las Vegas, United States, 89119 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ottawa Hospital-Riverside Campus Ottawa, Canada, K1H 7W9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Alpha Recherche Clinique LB9 Quebec, Canada, G2J 0C4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Viable Clinical Research Corporation Scarborough, Canada, M1P 2T7 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Manna Research (Ottawa) Nepean, Canada, K2J 4A7 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Manna Research (Burlington North) Burlington, Canada, L7M 4Y1 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Manna Research (Montreal) Pointe-Claire, Canada, H9R 4S3 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Manna Research (Quebec) Levis, Canada, G6W 0M5 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHR de la Citadelle - Department of Gynaecology & Obstetrics LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU Saint-Pierre/UMC Sint-Pieter BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Femicare vzw Tienen, Belgium, 3300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lääkärikeskus Gyneko Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HUS / Naistenklinikka Helsinki, Finland, 00029 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mehiläinen Kuopio Kuopio, Finland, 70100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Terveystalo Tampere Tampere, Finland, 33100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations H Univ. Virgen Rocío | Ginecología Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pihlajalinna Lääkärikeskus Oy, Savo-Karjala Joensuu, Finland, 80100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Institute of Clinical Research - Garden Grove Garden Grove, United States, 92844 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southern Clinical Research, LLC Zachary, United States, 70791 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigators Research Group, LLC Brownsburg, United States, 46112 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Boeson Research - Missoula Missoula, United States, 59804 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT for Women's Health - Nadezhda OOD Sofia, Bulgaria, 1330 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spec. Hospital for Active Treatment of Oncological Diseases Sofia, Bulgaria, 1233 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Maximos Ob/Gyn League City, United States, 77573 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MAC Research Centre - Manchester Manchester, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Boeson Research - Great Falls OBGYN Great Falls, United States, 59405 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HWC Women’s Research Center Englewood, United States, 45322 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spec.Hospital for obstetrics and gynecology Selena OOD Plovdiv, Bulgaria, 4002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
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])Timeframe: 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.Timeframe: 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.Timeframe: Baseline to Week 56
Additional Information
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