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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)

Sponsor
Bayer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05099159
Collaborator
(none)
370
Enrollment
116
Locations
2
Arms
20.6
Anticipated Duration (Months)
3.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Elinzanetant (BAY3427080)
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
370 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 29, 2021
Anticipated Primary Completion Date :
Mar 14, 2023
Anticipated Study Completion Date :
Jul 18, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Elinzanetant (BAY3427080)

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

Drug: Elinzanetant (BAY3427080)
120 mg elinzanetant orally once daily
Placebo Comparator: Placebo + elinzanetant

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

Drug: Elinzanetant (BAY3427080)
120 mg elinzanetant orally once daily

Drug: Placebo
Matching placebo orally once daily

Outcome Measures

Primary Outcome Measures

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

  2. Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD) [Baseline to Week 12]

  3. Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD) [Baseline to Week 4]

  4. Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD) [Baseline to Week 12]

Secondary Outcome Measures

  1. Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD) [Baseline to Week 1]

  2. Mean change in frequency of moderate to severe HF from baseline over time [Baseline to Week 26]

  3. 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 [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.

  4. Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12 [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.

  5. Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12 [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).

  6. Mean change in BDI-II total score from baseline to Week 26 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Accel Research Sites - Cahaba Medical Care Birmingham Alabama United States 35218
2 Onyx Clinical Research - Peoria Peoria Arizona United States 85381
3 Lynn Institute of the Ozarks Little Rock Arkansas United States 72204
4 Clinical Trials Research Lincoln California United States 95648
5 Torrance Clinical Research- Lomita Lomita California United States 90717
6 Womens Health Care Research Corporation San Diego California United States 92111
7 West Coast OB/GYN Associates San Diego California United States 92123
8 Advanced Women's Health Institute Greenwood Village Colorado United States 80111
9 Physicians Research Options, LLC Lakewood Colorado United States 80228
10 Helix Biomedics, LLC Boynton Beach Florida United States 33435
11 Clinical Research of West Florida, Inc - Clearwater Clearwater Florida United States 33603
12 Clinical Research of West Florida, Inc. Clearwater Florida United States 33765
13 Sweet Hope Research Specialty, Inc. - Miami Lakes Hialeah Florida United States 33016
14 Ocean Blue Medical Research Center, Inc. Miami Springs Florida United States 33166
15 Suncoast Clinical Research Center, Inc. New Port Richey Florida United States 34652
16 Sensible Healthcare, LLC Ocoee Florida United States 34761
17 Fellows Research Alliance - Savannah Savannah Georgia United States 31406
18 Family Care Research Boise Idaho United States 83713
19 Leavitt Clinical Research Idaho Falls Idaho United States 83404
20 Univ of Chicago | Obs and Gynae Chicago Illinois United States 60637
21 Affinity Healthcare, LLC Oak Brook Illinois United States 60523
22 Clinical Trials Management, LLC - Covington Covington Louisiana United States 70433
23 Tandem Clinical Research Marrero Louisiana United States 70072
24 Ob and Gyn Physicians MidAtlantic - SKYCRNG Oxon Hill Maryland United States 20705
25 Genesis Clinical Research and Consulting, LLC Fall River Massachusetts United States 02723
26 Saginaw Valley Medical Research Group, LLC Saginaw Michigan United States 48604
27 Metro Jackson OB-GYN Jackson Mississippi United States 39202
28 Las Vegas Gynecology Las Vegas Nevada United States 89128
29 Lawrence OB/GYN Associates Lawrenceville New Jersey United States 08648
30 Columbia University Medical Center New York New York United States 10032
31 Eastern Carolina Women's Center New Bern North Carolina United States 28562
32 Unified Women's Clinical Research - Raleigh Raleigh North Carolina United States 27607
33 Oregon Health and Science Univ | OHSU OBGYN-Women's Hlth Res Portland Oregon United States 97239
34 Magee Womens Hospital of UPMC Pittsburgh Pennsylvania United States 15213-3180
35 Tribe Clinical Research Greenville South Carolina United States 29607
36 Medical Research Center of Memphis, LLC Memphis Tennessee United States 38120
37 Memphis Obstetrics and Gynecological Association, PC Memphis Tennessee United States 38120
38 DiscoveResearch, Inc. Bryan Texas United States 77802
39 South Texas Clinical Research Corpus Christi Texas United States 78413
40 Signature GYN Services, Pllc Fort Worth Texas United States 76104-4145
41 Advances in Health, Inc. Houston Texas United States 77030
42 Austin Regional Clinic Pflugerville Texas United States 78660
43 ClinRx Research, LLC Plano Texas United States 75024
44 Physicians' Research Options, LLC Draper Utah United States 84020
45 University of Virginia Midlife Health Center Charlottesville Virginia United States 22903
46 Northwest Clinical Research Center Bellevue Washington United States 98007
47 Alta Clinical Research Edmonton Alberta Canada T5A 4L8
48 IWK Health Centre Halifax Nova Scotia Canada B3K 6R8
49 Ottawa Hospital-Riverside Campus Ottawa Ontario Canada K1H 7W9
50 Viable Clinical Research Corporation Scarborough Ontario Canada M1P 2T7
51 Ecogene21 Chicoutimi Quebec Canada G7H 0S7
52 Clinique OVO Montreal Quebec Canada H4P 2S4
53 ALPHA Recherche Clinique Val-Bélair Quebec Canada G3K 2P8
54 Diex Recherche Victoriaville Inc. Victoriaville Quebec Canada G6P 6P6
55 Alpha Recherche Clinique LB9 Quebec Canada G2J 0C4
56 GynPorCentrum s.r.o. Krnov Czechia 794 01
57 MUDr. Martina Maresova Rosenbergova, gynekologie Plzen Czechia 300 01
58 Gynekologie Studentsky dum s.r.o. Praha 6 Czechia 160 00
59 GYNEVI s.r.o. Rokycany Czechia 337 22
60 Gynpraxetabor s.r.o. Tabor Czechia 39003
61 Synexus Frankfurt Clinical Research Centre Frankfurt Hessen Germany 60313
62 Praxis Fr. Dr. F. Greven Hannover Niedersachsen Germany 30459
63 Praxis Hr. Dr. S. Fiedler Aachen Nordrhein-Westfalen Germany 52074
64 Frauenärzte am Schloss Borbeck Essen Nordrhein-Westfalen Germany 45355
65 Medplus Nordrhein Krefeld Nordrhein-Westfalen Germany 47799
66 Praxis f. Gynäkologie und Geburtshilfe Bernburg Sachsen-Anhalt Germany 06406
67 Synexus Leipzig Clinical Research Centre Leipzig Sachsen Germany 04103
68 Femme Frauenarztpraxis Gera Thüringen Germany 07545
69 emovis GmbH Berlin Germany 10629
70 Synexus Clinical Research GmbH Berlin Germany 12627
71 Frauenarztpraxis Dr. Inka Kiesche Halle Germany 06110
72 A.O.U. Policlinico Federico II Napoli Napoli Campania Italy 80131
73 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Lazio Italy 00168
74 A.O. Ordine Mauriziano Torino Piemonte Italy 10128
75 A.O.U.I. Verona Verona Veneto Italy 37126
76 Kirkeparken Spesialistpraksis Fredrikstad Norway 1605
77 Medicus Oslo AS Oslo Norway 0161
78 OUS Ullevål Gynecology Department Oslo Norway 0450
79 Medicus Stavanger AS Stavanger Norway 4005
80 Medicus AS Trondheim Norway 7014
81 Gabinet Ginekologiczny Janusz Tomaszewski Bialystok Poland 15-244
82 CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice Poland 40-156
83 Centrum Medyczne Angelius Provita Katowice Poland 40-611
84 Vita Longa Sp. z o.o. Katowice Poland 40-748
85 Etyka Osrodek Badan Klinicznych Olsztyn Poland 10-117
86 Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin Poland 71-434
87 Hospital Beatriz Angelo Loures Lisboa Portugal 2674-514
88 ULSM - Hospital Pedro Hispano Matosinhos Porto Portugal 4464-513
89 Hospital da Luz - Setubal Setubal Setúbal Portugal 2900-722
90 CHUC - Hospitais da U. Coimbra - Servico de Ginecologia Coimbra Portugal 3004-561
91 Centro Hospitalar de Lisboa Ocidental Lisboa Portugal 1449-005
92 CHULN - H. Sta.Maria (Centro de Investigacao Clinica) Lisboa Portugal 1649-035
93 CHUP - Centro Materno-Infantil do Norte Porto Portugal 4050-651
94 Endocrinology Research Center Moscow Russian Federation 117036
95 Research Center for Obstetrics, Gynecology and Perinatology Moscow Russian Federation 177997
96 RC Medical Novosibirsk Russian Federation 630005
97 Close Joint Stock Company "Medical Company IDK" Samara Russian Federation 443072
98 Smolensk State Medical University Smolensk Russian Federation 214019
99 Siberian State Medical University Tomsk Russian Federation 634050
100 Univerzitna nemocnica Bratislava, Petrzalka Bratislava Slovakia 851 07
101 GYNARIN, s.r.o. Filakovo Slovakia 986 01
102 ULMUS, s r.o. Hlohovec Slovakia 920 01
103 GA Lucenec s.r.o Lucenec Slovakia 984 01
104 BrenCare, s.r.o. Poprad Slovakia 058 01
105 Virina sano, s.r.o. Gynekologicko porodnicka ambulancia Velky Krtis Slovakia 990 01
106 Kantonsspital Baden Baden Aargau Switzerland 5404
107 Universitätsspital Basel Basel Basel-Stadt Switzerland 4056
108 Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Vaud Switzerland 1011
109 Inselspital Universitätsspital Bern Bern Switzerland 3010
110 UniversitätsSpital Zürich Zürich Switzerland 8091
111 Ivano-Frankivsk Regional Perinatal Center Ivano-Frankivsk Ukraine 76018
112 Instr. of Pediatrics, Obstetrics & Gynecology Kiev Ukraine 04050
113 Center of innovative medical technologies of NAS of Ukraine Kiev Ukraine 04053
114 LLC "Medical center "Verum" Kyiv Ukraine 03039
115 Medical Center Motor Sich Zaporizhzhya Ukraine 69068
116 Zaporizhzhia Regional Clinical Hospital Zaporizhzhya Ukraine 69600

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT05099159
Other Study ID Numbers:
  • 21652
  • 2020-004855-34
First Posted:
Oct 29, 2021
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bayer
Menopause
Additional relevant MeSH terms:
Hot Flashes

Study Results

No Results Posted as of Jul 18, 2022