Clinical trial NCT05099159: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vasomotor Symptoms Associated With Menopause
Hot Flashes
Keywords: Menopause
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 400
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 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.

Primary outcomes:
measure: 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
measure: Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
timeFrame: Baseline to Week 12
measure: Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)
timeFrame: Baseline to Week 4
measure: Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)
timeFrame: Baseline to Week 1
measure: Mean change in frequency of moderate to severe HF from baseline over time
timeFrame: Baseline to Week 26
measure: 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
timeFrame: Baseline to Week 12
measure: Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12
timeFrame: Baseline to Week 12
measure: Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12
timeFrame: Baseline to Week 12
measure: Mean change in BDI-II total score from baseline to Week 26
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research Sites - Cahaba Medical Care
state: Alabama
city: Mobile
country: United States
facility: Women's Health Alliance of Mobile
state: Alabama
city: Peoria
country: United States
facility: Onyx Clinical Research - Peoria
state: Arizona
city: Garden Grove
country: United States
facility: National Institute of Clinical Research - Garden Grove
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research- Lomita
state: California
city: San Diego
country: United States
facility: Womens Health Care Research Corporation
state: California
city: Greenwood Village
country: United States
facility: Advanced Women's Health Institute
state: Colorado
city: Lakewood
country: United States
facility: Physicians Research Options, LLC
state: Colorado
city: Boynton Beach
country: United States
facility: Helix Biomedics, LLC
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc - Clearwater
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty, Inc. - Miami Lakes
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research Center, Inc.
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC
state: Florida
city: Savannah
country: United States
facility: Fellows Research Alliance - Savannah
state: Georgia
city: Boise
country: United States
facility: Family Care Research
state: Idaho
city: Idaho Falls
country: United States
facility: Leavitt Clinical Research | Idaho Falls, ID
state: Idaho
city: Oak Brook
country: United States
facility: Affinity Health Research Institute | Oak Brook, IL
state: Illinois
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Oxon Hill
country: United States
facility: Ob and Gyn Physicians MidAtlantic - SKYCRNG
state: Maryland
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group, LLC
state: Michigan
city: Jackson
country: United States
facility: Metro Jackson OB-GYN
state: Mississippi
city: Lawrenceville
country: United States
facility: Lawrence OB/GYN Associates
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Research - Raleigh
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science Univ | OHSU OBGYN-Women's Hlth Res
state: Oregon
city: Greenville
country: United States
facility: Tribe Clinical Research
state: South Carolina
city: Memphis
country: United States
facility: Medical Research Center of Memphis, LLC
state: Tennessee
city: Memphis
country: United States
facility: Memphis Obstetrics and Gynecological Association, PC
state: Tennessee
city: Bryan
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Corpus Christi
country: United States
facility: South Texas Clinical Research
state: Texas
city: Fort Worth
country: United States
facility: Signature GYN Services, Pllc
state: Texas
city: Houston
country: United States
facility: UT Health Women's Research Center at Memorial City
state: Texas
city: Houston
country: United States
facility: Advances in Health, Inc.
state: Texas
city: Pflugerville
country: United States
facility: Austin Regional Clinic
state: Texas
city: Plano
country: United States
facility: ClinRx Research, LLC
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Midlife Health Center
state: Virginia
city: Norfolk
country: United States
facility: Tidewater Clinical Research, Inc.
state: Virginia
city: Edmonton
country: Canada
facility: Alta Clinical Research
state: Alberta
city: Chicoutimi
country: Canada
facility: Ecogene21
state: Quebec
city: Montreal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Montreal
country: Canada
facility: Clinique OVO
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
city: Val-Bélair
country: Canada
facility: ALPHA Recherche Clinique
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Recherche Victoriaville Inc.
state: Quebec
city: Quebec
country: Canada
facility: Diex Recherche Quebec Inc.
city: Quebec
country: Canada
facility: Alpha Recherche Clinique | Lebourgneuf
city: Krnov
country: Czechia
facility: GynPorCentrum s.r.o.
city: Plzen
country: Czechia
facility: MUDr. Martina Maresova Rosenbergova, gynekologie
city: Praha 6
country: Czechia
facility: Gynekologie Studentsky dum s.r.o.
city: Rokycany
country: Czechia
facility: GYNEVI s.r.o.
city: Tabor
country: Czechia
facility: Gynpraxetabor s.r.o.
city: Frankfurt
country: Germany
facility: Synexus Frankfurt Clinical Research Centre
state: Hessen
city: Aachen
country: Germany
facility: Praxis Hr. Dr. S. Fiedler
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Frauenärzte am Schloss Borbeck
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
facility: Medplus Nordrhein
state: Nordrhein-Westfalen
city: Bernburg
country: Germany
facility: Praxis f. Gynäkologie und Geburtshilfe
state: Sachsen-Anhalt
city: Halle
country: Germany
facility: Frauenarztpraxis Dr. Inka Kiesche
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Synexus Leipzig Clinical Research Centre
state: Sachsen
city: Gera
country: Germany
facility: Femme Frauenarztpraxis
state: Thüringen
city: Berlin
country: Germany
facility: emovis GmbH
city: Berlin
country: Germany
facility: Synexus Berlin Clinical Research Centre
city: Napoli
country: Italy
facility: A.O.U. Policlinico Federico II Napoli
state: Campania
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Lazio
city: Torino
country: Italy
facility: A.O. Ordine Mauriziano
state: Piemonte
city: Verona
country: Italy
facility: A.O.U.I. Verona
state: Veneto
city: Fredrikstad
country: Norway
facility: Kirkeparken Spesialistpraksis
city: Oslo
country: Norway
facility: Medicus Oslo AS
city: Oslo
country: Norway
facility: OUS Ullevål Gynecology Department
city: Stavanger
country: Norway
facility: Medicus Stavanger AS
city: Trondheim
country: Norway
facility: Medicus AS
city: Bialystok
country: Poland
facility: Gabinet Ginekologiczny Janusz Tomaszewski
city: Katowice
country: Poland
facility: CLINICAL MEDICAL RESEARCH Sp. z o. o.
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Katowice
country: Poland
facility: Vita Longa Sp. z o.o.
city: Olsztyn
country: Poland
facility: Etyka Osrodek Badan Klinicznych
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Loures
country: Portugal
facility: Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica
state: Lisboa
city: Matosinhos
country: Portugal
facility: ULSM - Hospital Pedro Hispano
state: Porto
city: Setubal
country: Portugal
facility: Hospital da Luz - Setubal
state: Setúbal
city: Coimbra
country: Portugal
facility: CHUC - Hospitais da U. Coimbra - Servico de Ginecologia
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
city: Lisboa
country: Portugal
facility: CHULN - H. Sta.Maria (Centro de Investigacao Clinica)
city: Porto
country: Portugal
facility: CHUP - Servico de Investigacao Clinica
city: Filakovo
country: Slovakia
facility: GYNARIN, s.r.o.
city: Hlohovec
country: Slovakia
facility: ULMUS, s r.o.
city: Kosice - Saca
country: Slovakia
facility: Nemocnica AGEL Kocice-Saca a.s.
city: Lucenec
country: Slovakia
facility: GA Lucenec s.r.o
city: Baden
country: Switzerland
facility: Kantonsspital Baden
state: Aargau
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
Study officials:
References: