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)

Hot Flashes Clinical Trial

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: NCT05099159
• Other study ID #: 21652
• Secondary ID: 2020-004855-34
• Status: Completed
• Phase: Phase 3
• Start date: October 29, 2021
• Est. completion date: October 10, 2023

Study information

• Verified date: May 2024
• 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: 400
• Est. completion date: October 10, 2023
• Est. primary completion date: June 13, 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 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.

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

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Italy,  Norway,  Poland,  Portugal,  Slovakia,  Switzerland, 

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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