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

Hot Flashes Clinical Trial

— OASIS-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05042362
• Other study ID #: 21651
• Secondary ID: 2020-004908-33
• Status: Completed
• Phase: Phase 3
• Start date: August 27, 2021
• Est. completion date: November 27, 2023

Study information

• Verified date: December 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: November 27, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Postmenopausal, defined as:

1. at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or

2. 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

3. 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

4. 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.

Related Conditions & MeSH terms

• Hot Flashes
• Vasomotor Symptoms Associated With Menopause

Intervention

Drug:
• Elinzanetant (BAY3427080)
120 mg elinzanetant orally once daily
• Placebo
Matching placebo orally once daily

Locations

Country	Name	City	State
Austria	Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe	Graz	Steiermark
Austria	MedUni Innsbruck | Klinik fur Gyn Endo und Reproduktionsmed	Innsbruck	Tirol
Austria	AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie	Wien
Austria	AKH Wien | Gyn. Endokrinologie & Reproduktionsmedizin	Wien
Czechia	Gynekologie MEDA s.r.o.	Brno
Czechia	GYN-MIKA s.r.o.	Ceske Budejovice
Czechia	Gynekologie Cheb s.r.o.	Cheb
Czechia	GYN-F s.r.o.	Hradec Kralove
Czechia	MUDr. Stepan s.r.o.	Hradec Kralove
Czechia	Kestr-gyn s.r.o.	Nachod
Czechia	G-Centrum Olomouc s.r.o. Dr. Skrivanek	Olomouc
Czechia	PT-MEDICA s.r.o.	Prachatice
Greece	ARETAIEION University Hospital	Athens
Greece	University General Hospital of Heraklion	Heraklion
Greece	Ioannina University General Hospital	Ioannina
Greece	General Hospital of Thessaloniki Papageorgiou	Thessaloniki
Hungary	Tritonlife Medical Center	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	NAP-MED Egeszsegugyi Szolgaltato Kft	Debrecen
Hungary	Komaromi Selye Janos Korhaz	Komarom
Hungary	Rub-Int Noi Egeszsegcentrum	Szekesfehervar
Israel	Mayanei HaYeshua Medical Center	Bnei Brak
Israel	Hadassah Hebrew University Hospital Ein Kerem	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Health Corporation of Galilee Medical Center	Nahariya
Italy	A.O.U. Policlinico G.Rodolico-San Marco	Catania	Sicilia
Italy	A.O.U. Careggi	Firenze	Toscana
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	Ospedale San Raffaele s.r.l.	Milano	Lombardia
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia	Lombardia
Italy	A.O.U. Pisana	Pisa	Toscana
Netherlands	Flevoziekenhuis	Almere
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Diakonessenhuis	Utrecht
United States	Bosque Womens Care	Albuquerque	New Mexico
United States	Velocity Clinical Research - Albuquerque	Albuquerque	New Mexico
United States	The Iowa Clinic - Ankeny	Ankeny	Iowa
United States	Medisense, Inc.	Atlanta	Georgia
United States	Women Partners in Health Obstetrics & Gynecology (OB/GYN)	Austin	Texas
United States	Central Research Associates, Inc.	Birmingham	Alabama
United States	St. Vincent's Hospital - Birmingham	Birmingham	Alabama
United States	Investigators Research Group, LLC	Brownsburg	Indiana
United States	Medical University of South Carolina	Charleston	South Carolina
United States	OnSite Clinical Solutions, LLC	Charlotte	North Carolina
United States	Chattanooga Medical Research, LLC	Chattanooga	Tennessee
United States	Axia Women's Health | Seven Hills Women's Health Centers - Montgomery	Cincinnati	Ohio
United States	Paramount Research Solutions-College Park	College Park	Georgia
United States	Centricity Research formerly Aventiv - Columbus	Columbus	Ohio
United States	Cedar Health Research, LLC	Dallas	Texas
United States	Revive Research Institute, Inc. - Women's Health	Dearborn Heights	Michigan
United States	Soapstone Center for Clinical Research	Decatur	Georgia
United States	Diagnamics, Inc.	Encinitas	California
United States	HWC Women's Research Center	Englewood	Ohio
United States	Alliance for Multispecialty Research, LLC - Fort Meyers	Fort Myers	Florida
United States	HillTop Obstetrics & Gynecology	Franklin	Ohio
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Om Research, LLC	Lancaster	California
United States	Jubilee Clinical Research, Inc	Las Vegas	Nevada
United States	Office of Dr. Edmond Pack	Las Vegas	Nevada
United States	Wake Research - Clinical Research Center of Nevada, LLC	Las Vegas	Nevada
United States	Women's Health Research Center, LLC	Lawrenceville	New Jersey
United States	Maximos Ob/Gyn	League City	Texas
United States	Women's Clinic of Lincoln, PC	Lincoln	Nebraska
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Drug Studies America	Marietta	Georgia
United States	Women's Care Research Institute/Marion OBGYN, Inc.	Marion	Ohio
United States	University Hospitals Landerbrook Health Center	Mayfield Heights	Ohio
United States	Mesa Obstetricians and Gynecologists	Mesa	Arizona
United States	Southern Clinical Research Associates LLC	Metairie	Louisiana
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Venus Gynecology, LLC former Magnolia OB/GYN Research Center	Myrtle Beach	South Carolina
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Suncoast Clinical Research	Palm Harbor	Florida
United States	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Wake Research, Inc.	Raleigh	North Carolina
United States	Northern California Research | Sacramento	Sacramento	California
United States	Valley OB-GYN Clinic	Saginaw	Michigan
United States	Northeast Clinical Research of San Antonio, LLC	San Antonio	Texas
United States	Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	Physician Care Clinical Research	Sarasota	Florida
United States	MomDoc Women For Women	Scottsdale	Arizona
United States	Seattle Clinical Research Center	Seattle	Washington
United States	Alliance Research Institute	Tarzana	California
United States	Continental Clinical Solutions, LLC	Towson	Maryland
United States	Del Sol Research Management LLC	Tucson	Arizona
United States	Noble Clinical Research	Tucson	Arizona
United States	Office of Dr. James A. Simon, MD	Washington	District of Columbia
United States	Circuit Clinical OB/GYN Associates of WNY	West Seneca	New York
United States	United Women's Clinical Research - Lyndhurst	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Austria,  Czechia,  Greece,  Hungary,  Israel,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])		Baseline to Week 4
Primary	Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)		Baseline to Week 12
Primary	Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)		Baseline to Week 4
Primary	Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)		Baseline to Week 12
Secondary	Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)		Baseline to Week 1
Secondary	Mean change in frequency of moderate to severe HF from baseline over time		Baseline to Week 26
Secondary	Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12	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.	Baseline to Week 12
Secondary	Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12	The 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.	Baseline to Week 12
Secondary	Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12	The 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).	Baseline to Week 12
Secondary	Mean change in BDI-II total score from baseline to Week 26	The 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).	Baseline to Week 26

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