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

Hot Flashes Clinical Trial

— OASIS-3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05030584
• Other study ID #: 21810
• Secondary ID: 2021-000059-38
• Status: Completed
• Phase: Phase 3
• Start date: August 27, 2021
• Est. completion date: February 12, 2024

Study information

• Verified date: March 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: February 12, 2024
• Est. primary completion date: March 29, 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 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.

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

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Denmark,  Finland,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in frequency of moderate to severe hot flashes (HFs) from baseline to Week 12 (assessed by hot flash daily diary [HFDD])		Baseline to Week 12
Secondary	Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score over time.	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 56
Secondary	Mean change in menopause specific quality of life scale (MENQOL) total score over time	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: Vasomotor functioning, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicates if they have experienced the symptom (yes/no). If they select yes, they 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 56

External Links

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