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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 (OASIS-3)

Primary Purpose

Vasomotor Symptoms Associated With Menopause, Hot Flashes

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Elinzanetant (BAY3427080)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasomotor Symptoms Associated With Menopause focused on measuring Menopause

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mobile Ob-Gyn, PC
  • Mesa Obstetricians and Gynecologists
  • National Institute of Clinical Research - Garden Grove
  • Marvel Clinical Research, LLC
  • Empire Clinical Research
  • Coastal Connecticut Research, LLC
  • Office of Dr. James A. Simon, MD
  • David I Lubetkin, MD, LLC
  • Helix Biomedics, LLC
  • University of Florida College of Medicine
  • Suncoast Clinical Research Center, Inc.
  • Suncoast Clinical Research
  • Physician Care Clinical Research
  • Paramount Research Solutions-College Park
  • Investigators Research Group, LLC
  • Southern Clinical Research Associates LLC
  • Southern Clinical Research, LLC
  • Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob
  • Boeson Research - Great Falls OBGYN
  • Boeson Research - Missoula
  • Office of Dr. Edmond Pack
  • AMR Las Vegas
  • Las Vegas Clinical Trials, LLC
  • Wake Research, Inc.
  • Columbus OB-GYN/Radiant Research
  • HWC Women's Research Center
  • Clinical Research of Philadelphia, LLC
  • Venus Gynecology, LLC former Magnolia OB/GYN Research Center
  • UT Health Women's Research Center at Memorial City
  • Advances in Health, Inc.
  • Women's Health Texas
  • Maximos Ob/Gyn
  • Tidewater Physicians for Women
  • Eastern Virginia Medical School | OB/GYN Clinical Research Center
  • Seattle Clinical Research Center
  • CHU Saint-Pierre/UMC Sint-Pieter
  • UZ Gent
  • UZ Leuven Gasthuisberg
  • CHR de la Citadelle - Department of Gynaecology & Obstetrics
  • Femicare vzw
  • MC Asklepii OOD
  • MHAT Avis Medika
  • Multiprofile Hospital for Activ Treatment Plovdiv
  • Spec.Hospital for obstetrics and gynecology Selena OOD
  • MHAT Samokov
  • Spec. Hospital for Active Treatment of Oncological Diseases
  • MHAT for Women's Health - Nadezhda OOD
  • DCC Aleksandrovska
  • Medical Center Panaceya
  • MHAT Niamed
  • SHOGAT Prof Dimitar Stamatov
  • Manna Research (Burlington North)
  • Manna Research (Ottawa)
  • Ottawa Hospital-Riverside Campus
  • Viable Clinical Research Corporation
  • Manna Research (Quebec)
  • Manna Research (Montreal)
  • Alpha Recherche Clinique LB9
  • Sanos Clinic - Nordjylland
  • Sanos Clinic - Herlev
  • Sanos Clinic - Syddanmark
  • HUS / Naistenklinikka
  • Pihlajalinna Lääkärikeskus Oy, Savo-Karjala
  • Mehiläinen Kuopio
  • Lääkärikeskus Gyneko
  • Terveystalo Tampere
  • Gabinet Ginekologiczny Janusz Tomaszewski
  • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Centrum Medyczne Angelius Provita
  • Vita Longa Sp. z o.o.
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Centrum Badawcze Wspolczesnej Terapii
  • Hospital Sanitas La Zarzuela
  • Hospital de la Santa Creu i Sant Pau | Gynecology Department
  • Instituto Palacios de Salud y Medicina de la Mujer
  • H Univ. 12 de Octubre | Ginecología y Obstetricia
  • H Univ. Virgen Rocío | Ginecología
  • Hospital Clinico Universitario | Gynecology and Obstetrics Department
  • MAC Research Centre Blackpool
  • Glasgow Royal Infirmary | Haematology
  • Liverpool Womens Hospital
  • Queen Charlottes & Chelseas Hospital
  • MAC Research Centre - Manchester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Elinzanetant (BAY3427080)

Placebo

Arm Description

Participants will receive 120 mg elinzanetant orally once daily.

Participants will receive matching placebo orally once daily.

Outcomes

Primary Outcome Measures

Mean change in frequency of moderate to severe hot flashes (HFs) from baseline to Week 12 (assessed by hot flash daily diary [HFDD])

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 27, 2021
Last Updated
October 24, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT05030584
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
March 29, 2023 (Actual)
Study Completion Date
January 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasomotor Symptoms Associated With Menopause, Hot Flashes
Keywords
Menopause

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
628 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elinzanetant (BAY3427080)
Arm Type
Active Comparator
Arm Description
Participants will receive 120 mg elinzanetant orally once daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo orally once daily.
Intervention Type
Drug
Intervention Name(s)
Elinzanetant (BAY3427080)
Intervention Description
120 mg elinzanetant orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo orally once daily.
Primary Outcome Measure Information:
Title
Mean change in frequency of moderate to severe hot flashes (HFs) from baseline to Week 12 (assessed by hot flash daily diary [HFDD])
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score over time.
Description
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.
Time Frame
Baseline to Week 56
Title
Mean change in menopause specific quality of life scale (MENQOL) total score over time
Description
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.
Time Frame
Baseline to Week 56

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal, defined as: at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or 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 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 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.
Facility Information:
Facility Name
Mobile Ob-Gyn, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608-6703
Country
United States
Facility Name
Mesa Obstetricians and Gynecologists
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
National Institute of Clinical Research - Garden Grove
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Marvel Clinical Research, LLC
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Empire Clinical Research
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Coastal Connecticut Research, LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Office of Dr. James A. Simon, MD
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
David I Lubetkin, MD, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Helix Biomedics, LLC
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
University of Florida College of Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Suncoast Clinical Research Center, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Suncoast Clinical Research
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Physician Care Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Paramount Research Solutions-College Park
City
College Park
State/Province
Georgia
ZIP/Postal Code
30349
Country
United States
Facility Name
Investigators Research Group, LLC
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
Southern Clinical Research Associates LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Southern Clinical Research, LLC
City
Zachary
State/Province
Louisiana
ZIP/Postal Code
70791
Country
United States
Facility Name
Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Boeson Research - Great Falls OBGYN
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Boeson Research - Missoula
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Office of Dr. Edmond Pack
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
AMR Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Las Vegas Clinical Trials, LLC
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Columbus OB-GYN/Radiant Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
HWC Women's Research Center
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Clinical Research of Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Venus Gynecology, LLC former Magnolia OB/GYN Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
UT Health Women's Research Center at Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Advances in Health, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Women's Health Texas
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Maximos Ob/Gyn
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Tidewater Physicians for Women
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Eastern Virginia Medical School | OB/GYN Clinical Research Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Seattle Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
CHU Saint-Pierre/UMC Sint-Pieter
City
Bruxelles - Brussel
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHR de la Citadelle - Department of Gynaecology & Obstetrics
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Femicare vzw
City
Tienen
ZIP/Postal Code
3300
Country
Belgium
Facility Name
MC Asklepii OOD
City
Dupnitza
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
MHAT Avis Medika
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Multiprofile Hospital for Activ Treatment Plovdiv
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Spec.Hospital for obstetrics and gynecology Selena OOD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
MHAT Samokov
City
Samokov
ZIP/Postal Code
2000
Country
Bulgaria
Facility Name
Spec. Hospital for Active Treatment of Oncological Diseases
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
MHAT for Women's Health - Nadezhda OOD
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
DCC Aleksandrovska
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Medical Center Panaceya
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
MHAT Niamed
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
SHOGAT Prof Dimitar Stamatov
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Manna Research (Burlington North)
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
Manna Research (Ottawa)
City
Nepean
State/Province
Ontario
ZIP/Postal Code
K2J 4A7
Country
Canada
Facility Name
Ottawa Hospital-Riverside Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
Facility Name
Viable Clinical Research Corporation
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P 2T7
Country
Canada
Facility Name
Manna Research (Quebec)
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W 0M5
Country
Canada
Facility Name
Manna Research (Montreal)
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Alpha Recherche Clinique LB9
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Facility Name
Sanos Clinic - Nordjylland
City
Gandrup
ZIP/Postal Code
9362
Country
Denmark
Facility Name
Sanos Clinic - Herlev
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Sanos Clinic - Syddanmark
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
HUS / Naistenklinikka
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Pihlajalinna Lääkärikeskus Oy, Savo-Karjala
City
Joensuu
ZIP/Postal Code
80100
Country
Finland
Facility Name
Mehiläinen Kuopio
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Lääkärikeskus Gyneko
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Terveystalo Tampere
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Gabinet Ginekologiczny Janusz Tomaszewski
City
Bialystok
ZIP/Postal Code
15-244
Country
Poland
Facility Name
CLINICAL MEDICAL RESEARCH Sp. z o. o.
City
Katowice
ZIP/Postal Code
40-156
Country
Poland
Facility Name
Centrum Medyczne Angelius Provita
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Vita Longa Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Centrum Badawcze Wspolczesnej Terapii
City
Warszawa
ZIP/Postal Code
02-679
Country
Poland
Facility Name
Hospital Sanitas La Zarzuela
City
Aravaca
State/Province
Madrid
ZIP/Postal Code
28023
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau | Gynecology Department
City
Barcelona
ZIP/Postal Code
8041
Country
Spain
Facility Name
Instituto Palacios de Salud y Medicina de la Mujer
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
H Univ. 12 de Octubre | Ginecología y Obstetricia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
H Univ. Virgen Rocío | Ginecología
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario | Gynecology and Obstetrics Department
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
MAC Research Centre Blackpool
City
Blackpool
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary | Haematology
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Liverpool Womens Hospital
City
Liverpool
ZIP/Postal Code
L8 7SS
Country
United Kingdom
Facility Name
Queen Charlottes & Chelseas Hospital
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Facility Name
MAC Research Centre - Manchester
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Links:
URL
https://clinicaltrials.bayer.com/study/21810
Description
Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

Learn more about this trial

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

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