Clinical trial NCT05042362: 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
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: 2021-09-13
Enrollment: 396
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 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.

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 T-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: Alabama Clinical Therapeutics | Birmingham, AL
state: Alabama
city: Birmingham
country: United States
facility: Central Research Associates | Birmingham, AL
state: Alabama
city: Mesa
country: United States
facility: Mesa Obstetricians and Gynecologists
state: Arizona
city: Scottsdale
country: United States
facility: MomDoc Women For Women
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management LLC
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Encinitas
country: United States
facility: Diagnamics, Inc.
state: California
city: Lancaster
country: United States
facility: Om Research, LLC
state: California
city: Sacramento
country: United States
facility: Northern California Research | Sacramento
state: California
city: Tarzana
country: United States
facility: Alliance Research Institute | Bell Gardens, CA
state: California
city: Washington
country: United States
facility: Office of Dr. James A. Simon, MD
state: District of Columbia
city: Fort Myers
country: United States
facility: Alliance for Multispecialty Research, LLC - Fort Meyers
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Medisense, Inc.
state: Georgia
city: College Park
country: United States
facility: Paramount Research Solutions-College Park
state: Georgia
city: Decatur
country: United States
facility: Soapstone Center for Clinical Research
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research, LLC
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Brownsburg
country: United States
facility: Investigators Research Group, LLC
state: Indiana
city: Ankeny
country: United States
facility: The Iowa Clinic - Ankeny
state: Iowa
city: Metairie
country: United States
facility: Southern Clinical Research Associates LLC
state: Louisiana
city: Towson
country: United States
facility: Continental Clinical Solutions | Towson, MD
state: Maryland
city: Dearborn Heights
country: United States
facility: Revive Research Institute, Inc. - Women's Health
state: Michigan
city: Saginaw
country: United States
facility: Valley OB-GYN Clinic
state: Michigan
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
city: Las Vegas
country: United States
facility: Jubilee Clinical Research, Inc
state: Nevada
city: Las Vegas
country: United States
facility: Office of Dr. Edmond Pack
state: Nevada
city: Las Vegas
country: United States
facility: Wake Research - Clinical Research Center of Nevada, LLC
state: Nevada
city: Lawrenceville
country: United States
facility: The Center for Womens Health & Wellness, LLC | Lawrenceville, NJ
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Albuquerque
country: United States
facility: Velocity Clinical Research - Albuquerque
state: New Mexico
city: Albuquerque
country: United States
facility: Bosque Womens Care
state: New Mexico
city: West Seneca
country: United States
facility: Circuit Clinical OB/GYN Associates of WNY
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: United Women's Clinical Research - Lyndhurst
state: North Carolina
city: Cincinnati
country: United States
facility: Axia Women's Health | Seven Hills Women's Health Centers - Montgomery
state: Ohio
city: Columbus
country: United States
facility: Centricity Research formerly Aventiv - Columbus
state: Ohio
city: Englewood
country: United States
facility: HWC Women's Research Center | Englewood, OH
state: Ohio
city: Franklin
country: United States
facility: HillTop Obstetrics & Gynecology
state: Ohio
city: Marion
country: United States
facility: Women's Care Research Institute/Marion OBGYN, Inc.
state: Ohio
city: Mayfield Heights
country: United States
facility: University Hospitals Landerbrook Health Center
state: Ohio
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina | MUSC Center for Womens Health - Department of Obstetrics and Gynecology
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center | Mount Pleasant, SC
state: South Carolina
city: Myrtle Beach
country: United States
facility: Venus Gynecology, LLC former Magnolia OB/GYN Research Center
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Austin
country: United States
facility: Women Partners in Health Obstetrics & Gynecology (OB/GYN)
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research, LLC
state: Texas
city: League City
country: United States
facility: Maximos Ob/Gyn
state: Texas
city: San Antonio
country: United States
facility: Northeast Clinical Research of San Antonio, LLC
state: Texas
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
city: Graz
country: Austria
facility: Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe
state: Steiermark
city: Innsbruck
country: Austria
facility: MedUni Innsbruck | Klinik fur Gyn Endo und Reproduktionsmed
state: Tirol
city: Wien
country: Austria
facility: AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie
city: Wien
country: Austria
facility: AKH Wien | Gyn. Endokrinologie & Reproduktionsmedizin
city: Brno
country: Czechia
facility: Gynekologie MEDA s.r.o.
city: Ceske Budejovice
country: Czechia
facility: GYN-MIKA s.r.o.
city: Cheb
country: Czechia
facility: Gynekologie Cheb s.r.o.
city: Hradec Kralove
country: Czechia
facility: MUDr. Stepan s.r.o.
city: Hradec Kralove
country: Czechia
facility: GYN-F s.r.o.
city: Nachod
country: Czechia
facility: Kestr-gyn s.r.o.
city: Olomouc
country: Czechia
facility: G-Centrum Olomouc s.r.o. Dr. Skrivanek
city: Prachatice
country: Czechia
facility: PT-MEDICA s.r.o.
city: Athens
country: Greece
facility: ARETAIEION University Hospital
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Ioannina
country: Greece
facility: Ioannina University General Hospital
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Papageorgiou
city: Budapest
country: Hungary
facility: TritonLife Medical Center, XIII.kerulet
city: Debrecen
country: Hungary
facility: NAP-MED Egeszsegugyi Szolgaltato Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Komarom
country: Hungary
facility: Komaromi Selye Janos Korhaz
city: Szekesfehervar
country: Hungary
facility: Rub-Int Noi Egeszsegcentrum
city: Bnei Brak
country: Israel
facility: Mayanei HaYeshua Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Hospital Ein Kerem
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Health Corporation of Galilee Medical Center
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele s.r.l.
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
state: Lombardia
city: Catania
country: Italy
facility: A.O.U. Policlinico G.Rodolico-San Marco
state: Sicilia
city: Firenze
country: Italy
facility: A.O.U. Careggi
state: Toscana
city: Pisa
country: Italy
facility: A.O.U. Pisana
state: Toscana
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
References: