search
Back to results

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-1)

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 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.

Sites / Locations

  • Central Research Associates, Inc.
  • St. Vincent's Hospital - Birmingham
  • Mesa Obstetricians and Gynecologists
  • MomDoc Women For Women
  • Noble Clinical Research
  • Del Sol Research Management LLC
  • Applied Research Center of Arkansas
  • Diagnamics, Inc.
  • Om Research, LLC
  • Northern California Research | Sacramento
  • Alliance Research Institute
  • Office of Dr. James A. Simon, MD
  • Alliance for Multispecialty Research, LLC - Fort Meyers
  • Suncoast Clinical Research
  • Physician Care Clinical Research
  • Medisense, Inc.
  • Paramount Research Solutions-College Park
  • Soapstone Center for Clinical Research
  • Drug Studies America
  • Mount Vernon Clinical Research, LLC
  • Clinical Research Prime
  • Investigators Research Group, LLC
  • The Iowa Clinic - Ankeny
  • Southern Clinical Research Associates LLC
  • Continental Clinical Solutions, LLC
  • Revive Research Institute, Inc. - Women's Health
  • Valley OB-GYN Clinic
  • Women's Clinic of Lincoln, PC
  • Jubilee Clinical Research, Inc
  • Office of Dr. Edmond Pack
  • Wake Research - Clinical Research Center of Nevada, LLC
  • Women's Health Research Center, LLC
  • Rutgers Robert Wood Johnson Medical School
  • Velocity Clinical Research - Albuquerque
  • Bosque Womens Care
  • Circuit Clinical OB/GYN Associates of WNY
  • OnSite Clinical Solutions, LLC
  • Wake Research, Inc.
  • United Women's Clinical Research - Lyndhurst
  • Axia Women's Health | Seven Hills Women's Health Centers - Montgomery
  • Centricity Research formerly Aventiv - Columbus
  • HWC Women's Research Center
  • HillTop Obstetrics & Gynecology
  • Women's Care Research Institute/Marion OBGYN, Inc.
  • University Hospitals Landerbrook Health Center
  • Clinical Research of Philadelphia, LLC
  • Medical University of South Carolina
  • Coastal Carolina Research Center
  • Venus Gynecology, LLC former Magnolia OB/GYN Research Center
  • Chattanooga Medical Research, LLC
  • Women Partners in Health Obstetrics & Gynecology (OB/GYN)
  • Cedar Health Research, LLC
  • Maximos Ob/Gyn
  • Northeast Clinical Research of San Antonio, LLC
  • Seattle Clinical Research Center
  • Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe
  • MedUni Innsbruck | Klinik fur Gyn Endo und Reproduktionsmed
  • AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie
  • AKH Wien | Gyn. Endokrinologie & Reproduktionsmedizin
  • Gynekologie MEDA s.r.o.
  • GYN-MIKA s.r.o.
  • Gynekologie Cheb s.r.o.
  • MUDr. Stepan s.r.o.
  • GYN-F s.r.o.
  • Kestr-gyn s.r.o.
  • G-Centrum Olomouc s.r.o. Dr. Skrivanek
  • PT-MEDICA s.r.o.
  • ARETAIEION University Hospital
  • University General Hospital of Heraklion
  • Ioannina University General Hospital
  • General Hospital of Thessaloniki Papageorgiou
  • Tritonlife Medical Center
  • NAP-MED Egeszsegugyi Szolgaltato Kft
  • Debreceni Egyetem Klinikai Kozpont
  • Komaromi Selye Janos Korhaz
  • Rub-Int Noi Egeszsegcentrum
  • Mayanei HaYeshua Medical Center
  • Hadassah Hebrew University Hospital Ein Kerem
  • Meir Medical Center
  • Health Corporation of Galilee Medical Center
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Ospedale San Raffaele s.r.l.
  • Fondazione IRCCS Policlinico San Matteo
  • A.O.U. Policlinico G.Rodolico-San Marco
  • A.O.U. Careggi
  • A.O.U. Pisana
  • Flevoziekenhuis
  • St. Antonius Ziekenhuis
  • Diakonessenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Elinzanetant (BAY3427080)

Placebo + elinzanetant

Arm Description

Participants will receive 120 mg elinzanetant orally once daily for 26 weeks.

Participants will receive matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks.

Outcomes

Primary Outcome Measures

Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])
Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)
Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)

Secondary Outcome Measures

Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)
Mean change in frequency of moderate to severe HF from baseline over time
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.
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.
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).
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).

Full Information

First Posted
August 26, 2021
Last Updated
October 7, 2023
Sponsor
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT05042362
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 26 Weeks in Women Who Have Been Through the Menopause
Acronym
OASIS-1
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
November 21, 2023 (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 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.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
396 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elinzanetant (BAY3427080)
Arm Type
Experimental
Arm Description
Participants will receive 120 mg elinzanetant orally once daily for 26 weeks.
Arm Title
Placebo + elinzanetant
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks.
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 flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])
Time Frame
Baseline to Week 4
Title
Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
Time Frame
Baseline to Week 12
Title
Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)
Time Frame
Baseline to Week 4
Title
Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)
Time Frame
Baseline to Week 1
Title
Mean change in frequency of moderate to severe HF from baseline over time
Time Frame
Baseline to Week 26
Title
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
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 12
Title
Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12
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: 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.
Time Frame
Baseline to Week 12
Title
Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12
Description
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).
Time Frame
Baseline to Week 12
Title
Mean change in BDI-II total score from baseline to Week 26
Description
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).
Time Frame
Baseline to Week 26

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 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.
Facility Information:
Facility Name
Central Research Associates, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
St. Vincent's Hospital - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Mesa Obstetricians and Gynecologists
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
MomDoc Women For Women
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Noble Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Del Sol Research Management LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Applied Research Center of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Diagnamics, Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Om Research, LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Northern California Research | Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Alliance Research Institute
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
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
Alliance for Multispecialty Research, LLC - Fort Meyers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
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
Medisense, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30363
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
Soapstone Center for Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Mount Vernon Clinical Research, LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30126
Country
United States
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigators Research Group, LLC
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
The Iowa Clinic - Ankeny
City
Ankeny
State/Province
Iowa
ZIP/Postal Code
50023
Country
United States
Facility Name
Southern Clinical Research Associates LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Continental Clinical Solutions, LLC
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Revive Research Institute, Inc. - Women's Health
City
Dearborn Heights
State/Province
Michigan
ZIP/Postal Code
48127
Country
United States
Facility Name
Valley OB-GYN Clinic
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Women's Clinic of Lincoln, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Jubilee Clinical Research, Inc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
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
Wake Research - Clinical Research Center of Nevada, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Women's Health Research Center, LLC
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Velocity Clinical Research - Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87107
Country
United States
Facility Name
Bosque Womens Care
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Circuit Clinical OB/GYN Associates of WNY
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
OnSite Clinical Solutions, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
United Women's Clinical Research - Lyndhurst
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Axia Women's Health | Seven Hills Women's Health Centers - Montgomery
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Centricity Research formerly Aventiv - Columbus
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
HillTop Obstetrics & Gynecology
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-2593
Country
United States
Facility Name
Women's Care Research Institute/Marion OBGYN, Inc.
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
University Hospitals Landerbrook Health Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Clinical Research of Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
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
Chattanooga Medical Research, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Women Partners in Health Obstetrics & Gynecology (OB/GYN)
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Cedar Health Research, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Maximos Ob/Gyn
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Northeast Clinical Research of San Antonio, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Seattle Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
MedUni Innsbruck | Klinik fur Gyn Endo und Reproduktionsmed
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
AKH Wien | Gyn. Endokrinologie & Reproduktionsmedizin
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Gynekologie MEDA s.r.o.
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
GYN-MIKA s.r.o.
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Gynekologie Cheb s.r.o.
City
Cheb
ZIP/Postal Code
350 02
Country
Czechia
Facility Name
MUDr. Stepan s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czechia
Facility Name
GYN-F s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 03
Country
Czechia
Facility Name
Kestr-gyn s.r.o.
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
G-Centrum Olomouc s.r.o. Dr. Skrivanek
City
Olomouc
ZIP/Postal Code
772 00
Country
Czechia
Facility Name
PT-MEDICA s.r.o.
City
Prachatice
ZIP/Postal Code
383 01
Country
Czechia
Facility Name
ARETAIEION University Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
Ioannina University General Hospital
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
General Hospital of Thessaloniki Papageorgiou
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
Facility Name
Tritonlife Medical Center
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
NAP-MED Egeszsegugyi Szolgaltato Kft
City
Debrecen
ZIP/Postal Code
4028
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Komaromi Selye Janos Korhaz
City
Komarom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Rub-Int Noi Egeszsegcentrum
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Mayanei HaYeshua Medical Center
City
Bnei Brak
ZIP/Postal Code
5154475
Country
Israel
Facility Name
Hadassah Hebrew University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Health Corporation of Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale San Raffaele s.r.l.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
A.O.U. Policlinico G.Rodolico-San Marco
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
A.O.U. Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
A.O.U. Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
Flevoziekenhuis
City
Almere
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Diakonessenhuis
City
Utrecht
ZIP/Postal Code
3582 KE
Country
Netherlands

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/21651
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 26 Weeks in Women Who Have Been Through the Menopause

We'll reach out to this number within 24 hrs