Clinical trial NCT05030584: 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 52 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 52 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: 2021-09-01
Enrollment: 628
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 they 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 is a treatment that looks like a medicine but does not have any medicine in it. To compare these study treatments, the participants will record information about their hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe they are. They will study the results from before treatment 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 will take the study treatments for 52 weeks.

During the study, the participants will visit their study site approximately 11 times and perform 2 visits by phone. Each participant will be in the study for approximately 62 weeks.

During the study, the participants will:

* record information about their hot flashes in an electronic diary
* answer questions about their symptoms

The doctors will:

* check the participants' health
* take blood samples
* ask the participants questions about what medicines they are taking and if they 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 they 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 is showing eligibility with respect to previous inclusion criterion during this time period.

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 flashes (HFs) from baseline to Week 12 (assessed by hot flash daily diary [HFDD])
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score over time.
timeFrame: Baseline to Week 56
measure: Mean change in menopause specific quality of life scale (MENQOL) total score over time
timeFrame: Baseline to Week 56
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Ob-Gyn, PC
state: Alabama
city: Mesa
country: United States
facility: Mesa Obstetricians and Gynecologists
state: Arizona
city: Garden Grove
country: United States
facility: National Institute of Clinical Research - Garden Grove
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research, LLC
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Washington
country: United States
facility: Office of Dr. James A. Simon, MD
state: District of Columbia
city: Boca Raton
country: United States
facility: David I Lubetkin, MD, LLC
state: Florida
city: Boynton Beach
country: United States
facility: Helix Biomedics, LLC
state: Florida
city: Jacksonville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research Center, Inc.
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: College Park
country: United States
facility: Paramount Research Solutions-College Park
state: Georgia
city: Brownsburg
country: United States
facility: Investigators Research Group, LLC
state: Indiana
city: Metairie
country: United States
facility: Southern Clinical Research Associates LLC
state: Louisiana
city: Zachary
country: United States
facility: Southern Clinical Research, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob
state: Maryland
city: Great Falls
country: United States
facility: Boeson Research - Great Falls OBGYN
state: Montana
city: Missoula
country: United States
facility: Boeson Research - Missoula
state: Montana
city: Las Vegas
country: United States
facility: Office of Dr. Edmond Pack
state: Nevada
city: Las Vegas
country: United States
facility: AMR Las Vegas
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials, LLC
state: Nevada
city: Raleigh
country: United States
facility: Wake Research, Inc.
state: North Carolina
city: Columbus
country: United States
facility: Columbus OB-GYN/Radiant Research
state: Ohio
city: Englewood
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Venus Gynecology, LLC former Magnolia OB/GYN Research Center
state: South Carolina
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: Katy
country: United States
facility: Women's Health Texas
state: Texas
city: League City
country: United States
facility: Maximos Ob/Gyn
state: Texas
city: Norfolk
country: United States
facility: Tidewater Physicians for Women
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School | OB/GYN Clinical Research Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
city: Bruxelles - Brussel
country: Belgium
facility: CHU Saint-Pierre/UMC Sint-Pieter
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liege
country: Belgium
facility: CHR de la Citadelle - Department of Gynaecology & Obstetrics
city: Tienen
country: Belgium
facility: Femicare vzw
city: Dupnitza
country: Bulgaria
facility: MC Asklepii OOD
city: Pleven
country: Bulgaria
facility: MHAT Avis Medika
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Activ Treatment Plovdiv
city: Plovdiv
country: Bulgaria
facility: Spec.Hospital for obstetrics and gynecology Selena OOD
city: Samokov
country: Bulgaria
facility: MHAT Samokov
city: Sofia
country: Bulgaria
facility: Spec. Hospital for Active Treatment of Oncological Diseases
city: Sofia
country: Bulgaria
facility: MHAT for Women's Health - Nadezhda OOD
city: Sofia
country: Bulgaria
facility: DCC Aleksandrovska
city: Sofia
country: Bulgaria
facility: Medical Center Panaceya
city: Stara Zagora
country: Bulgaria
facility: MHAT Niamed
city: Varna
country: Bulgaria
facility: SHOGAT Prof Dimitar Stamatov
city: Burlington
country: Canada
facility: Manna Research (Burlington North)
state: Ontario
city: Nepean
country: Canada
facility: Manna Research (Ottawa)
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital-Riverside Campus
state: Ontario
city: Scarborough
country: Canada
facility: Viable Clinical Research Corporation
state: Ontario
city: Levis
country: Canada
facility: Manna Research (Quebec)
state: Quebec
city: Pointe-Claire
country: Canada
facility: Manna Research (Montreal)
state: Quebec
city: Quebec
country: Canada
facility: Alpha Recherche Clinique LB9
city: Gandrup
country: Denmark
facility: Sanos Clinic - Nordjylland
city: Herlev
country: Denmark
facility: Sanos Clinic - Herlev
city: Vejle
country: Denmark
facility: Sanos Clinic - Syddanmark
city: Helsinki
country: Finland
facility: HUS / Naistenklinikka
city: Joensuu
country: Finland
facility: Pihlajalinna Lääkärikeskus Oy, Savo-Karjala
city: Kuopio
country: Finland
facility: Mehiläinen Kuopio
city: Oulu
country: Finland
facility: Lääkärikeskus Gyneko
city: Tampere
country: Finland
facility: Terveystalo Tampere
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: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Centrum Badawcze Wspolczesnej Terapii
city: Aravaca
country: Spain
facility: Hospital Sanitas La Zarzuela
state: Madrid
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau | Gynecology Department
city: Madrid
country: Spain
facility: Instituto Palacios de Salud y Medicina de la Mujer
city: Madrid
country: Spain
facility: H Univ. 12 de Octubre | Ginecología y Obstetricia
city: Sevilla
country: Spain
facility: H Univ. Virgen Rocío | Ginecología
city: Valencia
country: Spain
facility: Hospital Clinico Universitario | Gynecology and Obstetrics Department
city: Blackpool
country: United Kingdom
facility: MAC Research Centre Blackpool
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary | Haematology
city: Liverpool
country: United Kingdom
facility: Liverpool Womens Hospital
city: London
country: United Kingdom
facility: Queen Charlottes & Chelseas Hospital
city: Manchester
country: United Kingdom
facility: MAC Research Centre - Manchester
Study officials:
References: