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 26 weeks in women who have been through the menopause (OASIS-2)
Bayer Identifier:
21652
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 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:
• record information about the participants’ hot flashes in an electronic diary
• answer questions about the participants’ symptoms
The doctors will:
• check the participants’ health
• take blood samples
• ask the participants questions about what medicines the participants are taking and if the participants are having adverse events
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if doctors 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 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. • 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
| Locations | |
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Locations Praxis Hr. Dr. S. Fiedler Aachen, Germany, 52074 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations emovis GmbH Berlin, Germany, 10629 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Femme Frauenarztpraxis Gera, Germany, 07545 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Praxis f. Gynäkologie und Geburtshilfe Bernburg, Germany, 06406 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Frauenarztpraxis Dr. Inka Kiesche Halle, Germany, 06110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Frauenärzte am Schloss Borbeck Essen, Germany, 45355 | 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 Suncoast Clinical Research Center, Inc. New Port Richey, United States, 34652 | 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 Ocean Blue Medical Research Center, Inc. Miami Springs, United States, 33166 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Memphis Obstetrics and Gynecological Association, PC Memphis, United States, 38120 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Unified Women's Clinical Research - Raleigh Raleigh, United States, 27607 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oregon Health and Science Univ | OHSU OBGYN-Women's Hlth Res Portland, United States, 97239 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lawrence OB/GYN Associates Lawrenceville, United States, 08648 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Research of West Florida, Inc. Clearwater, United States, 33765 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Research Center of Memphis, LLC Memphis, United States, 38120 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Accel Research Sites - Cahaba Medical Care Birmingham, United States, 35218 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sweet Hope Research Specialty, Inc. - Miami Lakes Hialeah, United States, 33016 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Columbia University Medical Center New York, United States, 10032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Advanced Women's Health Institute Greenwood Village, United States, 80111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Signature GYN Services, Pllc Fort Worth, United States, 76104-4145 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Research of West Florida, Inc - Clearwater Clearwater, United States, 33603 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Affinity Health Research Institute | Oak Brook, IL Oak Brook, United States, 60523 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fellows Research Alliance - Savannah Savannah, United States, 31406 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Virginia Midlife Health Center Charlottesville, United States, 22903 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital Baden Baden, Switzerland, 5404 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tribe Clinical Research Greenville, United States, 29607 | 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 GA Lucenec s.r.o Lucenec, Slovakia, 984 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GYNARIN, s.r.o. Filakovo, Slovakia, 986 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ULMUS, s r.o. Hlohovec, Slovakia, 920 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinique OVO Montreal, Canada, H4P 2S4 | 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 ALPHA Recherche Clinique Val-Bélair, Canada, G3K 2P8 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Alta Clinical Research Edmonton, Canada, T5A 4L8 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kirkeparken Spesialistpraksis Fredrikstad, Norway, 1605 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations OUS Ullevål Gynecology Department Oslo, Norway, 0450 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medicus AS Trondheim, Norway, 7014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Trials Management, LLC - Covington Covington, United States, 70433 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne, Switzerland, 1011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saginaw Valley Medical Research Group, LLC Saginaw, United States, 48604 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHUC - Hospitais da U. Coimbra - Servico de Ginecologia Coimbra, Portugal, 3004-561 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHULN - H. Sta.Maria (Centro de Investigacao Clinica) Lisboa, Portugal, 1649-035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar de Lisboa Ocidental | Clin Res Dept Lisboa, Portugal, 1449-005 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital da Luz - Setubal Setubal, Portugal, 2900-722 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica Loures, Portugal, 2674-514 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ULSM - Hospital Pedro Hispano Matosinhos, Portugal, 4464-513 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DiscoveResearch, Inc. Bryan, United States, 77802 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Family Care Research Boise, United States, 83713 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diex Recherche Victoriaville Inc. Victoriaville, Canada, G6P 6P6 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UniversitätsSpital Zürich Zürich, Switzerland, 8091 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medicus Stavanger AS Stavanger, Norway, 4005 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medicus Oslo AS Oslo, Norway, 0161 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Womens Health Care Research Corporation San Diego, United States, 92111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Austin Regional Clinic Pflugerville, United States, 78660 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Trials Research Lincoln, United States, 95648 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Carolina Women's Center New Bern, United States, 28562 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Torrance Clinical Research- Lomita Lomita, United States, 90717 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Metro Jackson OB-GYN Jackson, United States, 39202 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Physicians Research Options, LLC Lakewood, United States, 80228 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Leavitt Clinical Research Idaho Falls, United States, 83404 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tandem Clinical Research Marrero, United States, 70072 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U.I. Verona Verona, Italy, 37126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. Ordine Mauriziano Torino, Italy, 10128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Policlinico Federico II Napoli Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medplus Nordrhein Krefeld, Germany, 47799 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gynekologie Studentsky dum s.r.o. Praha 6, Czech Republic, 160 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GYNEVI s.r.o. Rokycany, Czech Republic, 337 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GynPorCentrum s.r.o. Krnov, Czech Republic, 794 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gynpraxetabor s.r.o. Tabor, Czech Republic, 39003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Synexus Frankfurt Clinical Research Centre Frankfurt, Germany, 60313 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MUDr. Martina Maresova Rosenbergova, gynekologie Plzen, Czech Republic, 301 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Synexus Leipzig Clinical Research Centre Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHUP - Servico de Investigacao Clinica Porto, Portugal, 4050-651 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Synexus Clinical Research GmbH Berlin, Germany, 12627 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Etyka Osrodek Badan Klinicznych Olsztyn, Poland, 10-117 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ob and Gyn Physicians MidAtlantic - SKYCRNG Oxon Hill, United States, 20705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sensible Healthcare, LLC Ocoee, United States, 34761 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ClinRx Research, LLC Plano, United States, 75024 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations South Texas Clinical Research Corpus Christi, United States, 78413 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Onyx Clinical Research - Peoria Peoria, United States, 85381 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ecogene21 Chicoutimi, Canada, G7H 0S7 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Women's Health Alliance of Mobile Mobile, United States, 36604 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diex Recherche Quebec Inc. Quebec, Canada, G1V 4T3 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diex Recherche Sherbrooke Inc. Sherbrooke, Canada, J1L 0H8 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Recherche GCP Research Montreal, Canada, H1M 1B1 | 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 National Institute of Clinical Research - Garden Grove Garden Grove, United States, 92844 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnica AGEL Kocice-Saca a.s. Kosice - Saca, Slovakia, 040 15 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tidewater Clinical Research, Inc. Norfolk, United States, 23456 | 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 26 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 flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])Timeframe: Baseline to Week 4
- Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)Timeframe: Baseline to Week 12
- Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)Timeframe: Baseline to Week 4
- Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)Timeframe: Baseline to Week 12
Secondary Outcome
- Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)Timeframe: Baseline to Week 1
- Mean change in frequency of moderate to severe HF from baseline over timeTimeframe: Baseline to Week 26
- Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12The 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 12
- Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12The 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: VMS, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicates if they have experienced the symptom (yes/no). If participants select yes, participants 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 12
- Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12The BDI-II consists of 21 items to assess the severity of depression over the past 2 weeks. Each item is a list of four statements arranged in increasing levels of severity about a particular symptom of depression. Items use a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options are tailored to the aspect of depression being measured in each item. A total score ranging from 0 to 63 is calculated with scores of 0-13 indicating mild minimal range, 14 – 19 mild depression, 20 – 28 indicating moderate and 29 – 63 severe depression (higher score = greater depression).Timeframe: Baseline to Week 12
- Mean change in BDI-II total score from baseline to Week 26The BDI-II consists of 21 items to assess the severity of depression over the past 2 weeks. Each item is a list of four statements arranged in increasing levels of severity about a particular symptom of depression. Items use a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options are tailored to the aspect of depression being measured in each item. A total score ranging from 0 to 63 is calculated with scores of 0-13 indicating mild minimal range, 14 – 19 mild depression, 20 – 28 indicating moderate and 29 – 63 severe depression (higher score = greater depression).Timeframe: Baseline to Week 26
Additional Information
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