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-1)
Bayer Identifier:
21651
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 these women 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 | |
|---|---|
Locations Gynekologie MEDA s.r.o. Brno, Czech Republic, 602 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AKH Wien | Gyn. Endokrinologie & Reproduktionsmedizin Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MedUni Innsbruck | Klinik fur Gyn Endo und Reproduktionsmed Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Policlinico G.Rodolico-San Marco Catania, Italy, 95123 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione IRCCS Policlinico San Matteo Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale San Raffaele s.r.l. Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Careggi Firenze, Italy, 50134 | 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 Wake Research, Inc. Raleigh, United States, 27612 | 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 Women's Clinic of Lincoln, PC Lincoln, United States, 68510 | 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 Mesa Obstetricians and Gynecologists Mesa, United States, 85206 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PT-MEDICA s.r.o. Prachatice, Czech Republic, 383 01 | 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 Om Research, LLC Lancaster, United States, 93534 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centricity Research formerly Aventiv - Columbus Columbus, United States, 43213 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mount Vernon Clinical Research, LLC Sandy Springs, United States, 30126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chattanooga Medical Research, LLC Chattanooga, United States, 37404 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cedar Health Research, LLC Dallas, United States, 75251 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Coastal Carolina Research Center Mt. Pleasant, United States, 29464 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Women's Health Research Center, LLC Lawrenceville, United States, 08648 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diagnamics, Inc. Encinitas, United States, 92024 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Alliance for Multispecialty Research, LLC - Fort Meyers Fort Myers, United States, 33912 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospitals Landerbrook Health Center Mayfield Heights, United States, 44124 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Soapstone Center for Clinical Research Decatur, United States, 30034 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations United Women's Clinical Research - Lyndhurst Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HillTop Obstetrics & Gynecology Franklin, United States, 45005-2593 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Continental Clinical Solutions, LLC Towson, United States, 21204 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Vincent's Hospital - Birmingham Birmingham, United States, 35205 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Noble Clinical Research Tucson, United States, 85704 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Women Partners in Health Obstetrics & Gynecology (OB/GYN) Austin, United States, 78705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Valley OB-GYN Clinic Saginaw, United States, 48602 | 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 Medical University of South Carolina Charleston, United States, 29425 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bosque Womens Care Albuquerque, United States, 87109 | 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 Alliance Research Institute Tarzana, United States, 91356 | 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 Rutgers Robert Wood Johnson Medical School New Brunswick, United States, 08901 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MUDr. Stepan s.r.o. Hradec Kralove, Czech Republic, 500 02 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kestr-gyn s.r.o. Nachod, Czech Republic, 547 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Del Sol Research Management LLC Tucson, United States, 85715 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wake Research - Clinical Research Center of Nevada, LLC Las Vegas, United States, 89123 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MomDoc Women For Women Scottsdale, United States, 85251 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Pisana Pisa, Italy, 56126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations G-Centrum Olomouc s.r.o. Dr. Skrivanek Olomouc, Czech Republic, 772 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gynekologie Cheb s.r.o. Cheb, Czech Republic, 350 02 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Antonius Ziekenhuis Nieuwegein, Netherlands, 3435 CM | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Flevoziekenhuis Almere, Netherlands | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diakonessenhuis UTRECHT, Netherlands, 3582 KE | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medisense, Inc. Atlanta, United States, 30363 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Research Prime Idaho Falls, United States, 83404 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Health Corporation of Galilee Medical Center Nahariya, Israel, 2210001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mayanei HaYeshua Medical Center Bnei Brak, Israel, 5154475 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jubilee Clinical Research, Inc Las Vegas, United States, 89106 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ARETAIEION University Hospital Athens, Greece, 11528 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Hospital of Thessaloniki Papageorgiou Thessaloniki, Greece, 56403 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ioannina University General Hospital Ioannina, Greece, 45500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Heraklion Heraklion, Greece, 711 10 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Circuit Clinical OB/GYN Associates of WNY West Seneca, United States, 14224 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NAP-MED Egeszsegugyi Szolgaltato Kft Debrecen, Hungary, 4028 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Komaromi Selye Janos Korhaz Komarom, Hungary, 2900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tritonlife Medical Center Budapest, Hungary, 1134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rub-Int Noi Egeszsegcentrum Szekesfehervar, Hungary, 8000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GYN-MIKA s.r.o. Ceske Budejovice, Czech Republic, 370 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GYN-F s.r.o. Hradec Kralove, Czech Republic, 500 03 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Iowa Clinic - Ankeny Ankeny, United States, 50023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Revive Research Institute, Inc. - Women's Health Dearborn Heights, United States, 48127 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Applied Research Center of Arkansas Little Rock, United States, 72212 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations OnSite Clinical Solutions, LLC Charlotte, United States, 28277 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Axia Women's Health | Seven Hills Women's Health Centers - Montgomery Cincinnati, United States, 45242 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Drug Studies America Marietta, United States, 30060 | 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 Seattle Clinical Research Center Seattle, United States, 98105 | 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 Investigators Research Group, LLC Brownsburg, United States, 46112 | 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 Northern California Research | Sacramento Sacramento, United States, 95821 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Central Research Associates, Inc. Birmingham, United States, 35205 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northeast Clinical Research of San Antonio, LLC San Antonio, United States, 78233 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Women's Care Research Institute/Marion OBGYN, Inc. Marion, United States, 43302 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Velocity Clinical Research - Albuquerque Albuquerque, United States, 87107 | 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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