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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 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)

Primary Purpose

Vasomotor Symptoms Associated With Menopause, Hot Flashes

Status
Completed
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 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

  • Accel Research Sites - Cahaba Medical Care
  • Women's Health Alliance of Mobile
  • Onyx Clinical Research - Peoria
  • National Institute of Clinical Research - Garden Grove
  • Clinical Trials Research
  • Torrance Clinical Research- Lomita
  • Womens Health Care Research Corporation
  • Advanced Women's Health Institute
  • Physicians Research Options, LLC
  • Helix Biomedics, LLC
  • Clinical Research of West Florida, Inc - Clearwater
  • Clinical Research of West Florida, Inc.
  • Sweet Hope Research Specialty, Inc. - Miami Lakes
  • Ocean Blue Medical Research Center, Inc.
  • Suncoast Clinical Research Center, Inc.
  • Sensible Healthcare, LLC
  • Fellows Research Alliance - Savannah
  • Family Care Research
  • Leavitt Clinical Research
  • Affinity Health Research Institute | Oak Brook, IL
  • Clinical Trials Management, LLC - Covington
  • Tandem Clinical Research
  • Ob and Gyn Physicians MidAtlantic - SKYCRNG
  • Saginaw Valley Medical Research Group, LLC
  • Metro Jackson OB-GYN
  • Lawrence OB/GYN Associates
  • Columbia University Medical Center
  • Eastern Carolina Women's Center
  • Unified Women's Clinical Research - Raleigh
  • Oregon Health and Science Univ | OHSU OBGYN-Women's Hlth Res
  • Tribe Clinical Research
  • Medical Research Center of Memphis, LLC
  • Memphis Obstetrics and Gynecological Association, PC
  • DiscoveResearch, Inc.
  • South Texas Clinical Research
  • Signature GYN Services, Pllc
  • UT Health Women's Research Center at Memorial City
  • Advances in Health, Inc.
  • Austin Regional Clinic
  • ClinRx Research, LLC
  • University of Virginia Midlife Health Center
  • Tidewater Clinical Research, Inc.
  • Alta Clinical Research
  • Ecogene21
  • Recherche GCP Research
  • Clinique OVO
  • Diex Recherche Sherbrooke Inc.
  • ALPHA Recherche Clinique
  • Diex Recherche Victoriaville Inc.
  • Diex Recherche Quebec Inc.
  • Alpha Recherche Clinique LB9
  • GynPorCentrum s.r.o.
  • MUDr. Martina Maresova Rosenbergova, gynekologie
  • Gynekologie Studentsky dum s.r.o.
  • GYNEVI s.r.o.
  • Gynpraxetabor s.r.o.
  • Synexus Frankfurt Clinical Research Centre
  • Praxis Hr. Dr. S. Fiedler
  • Frauenärzte am Schloss Borbeck
  • Medplus Nordrhein
  • Praxis f. Gynäkologie und Geburtshilfe
  • Frauenarztpraxis Dr. Inka Kiesche
  • Synexus Leipzig Clinical Research Centre
  • Femme Frauenarztpraxis
  • emovis GmbH
  • Synexus Clinical Research GmbH
  • A.O.U. Policlinico Federico II Napoli
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • A.O. Ordine Mauriziano
  • A.O.U.I. Verona
  • Kirkeparken Spesialistpraksis
  • Medicus Oslo AS
  • OUS Ullevål Gynecology Department
  • Medicus Stavanger AS
  • Medicus AS
  • Gabinet Ginekologiczny Janusz Tomaszewski
  • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Centrum Medyczne Angelius Provita
  • Vita Longa Sp. z o.o.
  • Etyka Osrodek Badan Klinicznych
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica
  • ULSM - Hospital Pedro Hispano
  • Hospital da Luz - Setubal
  • CHUC - Hospitais da U. Coimbra - Servico de Ginecologia
  • Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
  • CHULN - H. Sta.Maria (Centro de Investigacao Clinica)
  • CHUP - Servico de Investigacao Clinica
  • GYNARIN, s.r.o.
  • ULMUS, s r.o.
  • Nemocnica AGEL Kocice-Saca a.s.
  • GA Lucenec s.r.o
  • Kantonsspital Baden
  • Centre Hospitalier Universitaire Vaudois (CHUV)
  • UniversitätsSpital Zürich

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
October 19, 2021
Last Updated
October 19, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT05099159
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 (OASIS-2)
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
Completed
Study Start Date
October 29, 2021 (Actual)
Primary Completion Date
June 13, 2023 (Actual)
Study Completion Date
October 4, 2023 (Actual)

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
400 (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 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
Accel Research Sites - Cahaba Medical Care
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35218
Country
United States
Facility Name
Women's Health Alliance of Mobile
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Onyx Clinical Research - Peoria
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
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
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Torrance Clinical Research- Lomita
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Womens Health Care Research Corporation
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Advanced Women's Health Institute
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Physicians Research Options, LLC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Helix Biomedics, LLC
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Clinical Research of West Florida, Inc - Clearwater
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Sweet Hope Research Specialty, Inc. - Miami Lakes
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Ocean Blue Medical Research Center, Inc.
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
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
Sensible Healthcare, LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Fellows Research Alliance - Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Family Care Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Leavitt Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Affinity Health Research Institute | Oak Brook, IL
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Clinical Trials Management, LLC - Covington
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Ob and Gyn Physicians MidAtlantic - SKYCRNG
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20705
Country
United States
Facility Name
Saginaw Valley Medical Research Group, LLC
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Metro Jackson OB-GYN
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Lawrence OB/GYN Associates
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Eastern Carolina Women's Center
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Unified Women's Clinical Research - Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Oregon Health and Science Univ | OHSU OBGYN-Women's Hlth Res
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Tribe Clinical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Medical Research Center of Memphis, LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Memphis Obstetrics and Gynecological Association, PC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
DiscoveResearch, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
South Texas Clinical Research
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78413
Country
United States
Facility Name
Signature GYN Services, Pllc
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-4145
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
Austin Regional Clinic
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
ClinRx Research, LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
University of Virginia Midlife Health Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Tidewater Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Alta Clinical Research
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5A 4L8
Country
Canada
Facility Name
Ecogene21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 0S7
Country
Canada
Facility Name
Recherche GCP Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Clinique OVO
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4P 2S4
Country
Canada
Facility Name
Diex Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
ALPHA Recherche Clinique
City
Val-Bélair
State/Province
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Diex Recherche Victoriaville Inc.
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
Diex Recherche Quebec Inc.
City
Quebec
ZIP/Postal Code
G1V 4T3
Country
Canada
Facility Name
Alpha Recherche Clinique LB9
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Facility Name
GynPorCentrum s.r.o.
City
Krnov
ZIP/Postal Code
794 01
Country
Czechia
Facility Name
MUDr. Martina Maresova Rosenbergova, gynekologie
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Facility Name
Gynekologie Studentsky dum s.r.o.
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
GYNEVI s.r.o.
City
Rokycany
ZIP/Postal Code
337 01
Country
Czechia
Facility Name
Gynpraxetabor s.r.o.
City
Tabor
ZIP/Postal Code
39003
Country
Czechia
Facility Name
Synexus Frankfurt Clinical Research Centre
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60313
Country
Germany
Facility Name
Praxis Hr. Dr. S. Fiedler
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Frauenärzte am Schloss Borbeck
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Medplus Nordrhein
City
Krefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47799
Country
Germany
Facility Name
Praxis f. Gynäkologie und Geburtshilfe
City
Bernburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06406
Country
Germany
Facility Name
Frauenarztpraxis Dr. Inka Kiesche
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06110
Country
Germany
Facility Name
Synexus Leipzig Clinical Research Centre
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Femme Frauenarztpraxis
City
Gera
State/Province
Thüringen
ZIP/Postal Code
07545
Country
Germany
Facility Name
emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
A.O.U. Policlinico Federico II Napoli
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O. Ordine Mauriziano
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
Facility Name
A.O.U.I. Verona
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Facility Name
Kirkeparken Spesialistpraksis
City
Fredrikstad
ZIP/Postal Code
1605
Country
Norway
Facility Name
Medicus Oslo AS
City
Oslo
ZIP/Postal Code
0161
Country
Norway
Facility Name
OUS Ullevål Gynecology Department
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Medicus Stavanger AS
City
Stavanger
ZIP/Postal Code
4005
Country
Norway
Facility Name
Medicus AS
City
Trondheim
ZIP/Postal Code
7014
Country
Norway
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
Etyka Osrodek Badan Klinicznych
City
Olsztyn
ZIP/Postal Code
10-117
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica
City
Loures
State/Province
Lisboa
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
ULSM - Hospital Pedro Hispano
City
Matosinhos
State/Province
Porto
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Hospital da Luz - Setubal
City
Setubal
State/Province
Setúbal
ZIP/Postal Code
2900-722
Country
Portugal
Facility Name
CHUC - Hospitais da U. Coimbra - Servico de Ginecologia
City
Coimbra
ZIP/Postal Code
3004-561
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
Facility Name
CHULN - H. Sta.Maria (Centro de Investigacao Clinica)
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
CHUP - Servico de Investigacao Clinica
City
Porto
ZIP/Postal Code
4050-651
Country
Portugal
Facility Name
GYNARIN, s.r.o.
City
Filakovo
ZIP/Postal Code
986 01
Country
Slovakia
Facility Name
ULMUS, s r.o.
City
Hlohovec
ZIP/Postal Code
920 01
Country
Slovakia
Facility Name
Nemocnica AGEL Kocice-Saca a.s.
City
Kosice - Saca
ZIP/Postal Code
040 15
Country
Slovakia
Facility Name
GA Lucenec s.r.o
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Kantonsspital Baden
City
Baden
State/Province
Aargau
ZIP/Postal Code
5404
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
UniversitätsSpital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

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/21652
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 (OASIS-2)

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