Trial Condition(s):
Vasomotor symptoms associated with menopause, Hot Flashes
Étude visant à en apprendre davantage sur l'efficacité et la sécurité d’emploi de l'élinzanétant dans le traitement des symptômes vasomoteurs (bouffées de chaleur) causés par les changements hormonaux pendant 26 semaines chez des femmes ménopausées (OASIS-2)
Bayer Identifier:
21652
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Objectif de l’essai
Les chercheurs sont à la recherche d'un meilleur moyen de traiter les femmes qui souffrent de bouffées de chaleur après la ménopause. Les bouffées de chaleur sont causées par les changements hormonaux qui se produisent lorsque le corps d'une femme a traversé la ménopause. La ménopause correspond au moment où les femmes arrêtent d'avoir un cycle menstruel, aussi appelé règles. Pendant la ménopause, les ovaires produisent de moins en moins d'hormones sexuelles en raison du processus naturel de vieillissement et des ajustements hormonaux associés. Pendant la ménopause, les ovaires produisent de moins en moins d'hormones sexuelles en raison du processus naturel de vieillissement et des ajustements hormonaux associés.
Le traitement à l'étude, l'elinzanetant, a été développé pour traiter les symptômes causés par les changements hormonaux. Il agit en empêchant une protéine appelée neurokinine d'envoyer des signaux à d'autres parties du corps, ce qui est censé jouer un rôle dans le déclenchement des bouffées de chaleur. Il existe des traitements contre les bouffées de chaleur chez les femmes ménopausées, mais ils peuvent causer des problèmes médicaux chez certaines personnes.
Dans cette étude, les chercheurs détermineront l'efficacité de l'elinzanetant par rapport à un placebo chez les femmes ménopausées souffrant de bouffées de chaleur. Un placebo ressemble à un traitement, mais ne contient aucun médicament. Pour comparer ces traitements à l'étude, les médecins demanderont aux participantes d'enregistrer des informations sur leurs bouffées de chaleur dans un journal électronique. Les chercheurs étudieront le nombre de bouffées de chaleur des participantes et leur gravité. Ils examineront les résultats avant le traitement, après 4 semaines et après 12 semaines de traitement.
Les participants à cette étude prendront deux gélules d'élinzanetant ou de placebo une fois par jour. Les participants qui prennent de l'elinzanetant le prendront pendant 26 semaines. Les participants qui prennent le placebo le prendront pendant 12 semaines, puis prendront de l'élinzanetant pendant 14 semaines suivantes.
Au cours de l’étude, les participantes se rendront au centre de l’étude environ 9 fois et effectueront une visite par téléphone. La participation à l’étude durera environ 36 semaines pour chaque participant. La durée du traitement sera de 26 semaines.
Au cours de l'étude, les participantes :
• record information about the participants’ hot flashes in an electronic diary
• answer questions about the participants’ symptoms
Les médecins :
• 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
Un événement indésirable est un problème d’ordre médical qu’un participant présente pendant une étude. Les médecins gardent une trace de tous les événements indésirables qui surviennent dans les études, même s’ils ne pensent pas que ces événements indésirables puissent être liés aux traitements à l’étude.
Critères d’inclusion
- Postmenopausal, defined as:
a. at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or
b. 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
c. 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
d. 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).Critères d’exclusion
- 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.
Résumé de l’essai
Enrollment Goal
Trial Dates
Phase
Est-il possible que je reçoive un placebo ?
Products
Accepts Healthy Volunteers
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Conception de l’essai
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])Timeframe: Baseline to Week 4
- Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)Timeframe: Baseline to Week 12
- Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)Timeframe: Baseline to Week 4
- Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)Timeframe: Baseline to Week 12
Secondary Outcome
- Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)Timeframe: Baseline to Week 1
- Mean change in frequency of moderate to severe HF from baseline over timeTimeframe: Baseline to Week 26
- Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12The 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.Timeframe: Baseline to Week 12
- Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12The 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.Timeframe: Baseline to Week 12
- Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12The 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).Timeframe: Baseline to Week 12
- Mean change in BDI-II total score from baseline to Week 26The 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).Timeframe: Baseline to Week 26
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