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)
3期
已完成
NCT05099159
| 适应症 | Vasomotor Symptoms Associated With Menopause, Hot Flashes |
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| 分期 | 3期 |
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| 申办方 | Bayer |
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| 状态 | 已完成 |
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| 受试者人数 | 400 人 |
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| 干预（药物） | Elinzanetant (BAY3427080) |
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| 开始日期 | 2021年10月29日 |
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| 完成日期 | 2023年6月13日 |
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| 结果公布日 | 2026年2月12日 |
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摘要
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 no
Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD)
From baseline to Week 4 · Hot Flashes per day
| Elinzanetant 120 mg | 14.66 ± 11.08 Hot Flashes per day |
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| Placebo - Elinzanetant 120 mg | 16.16 ± 11.15 Hot Flashes per day |
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| Elinzanetant 120 mg | -8.58 ± 9.16 Hot Flashes per day |
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| Placebo - Elinzanetant 120 mg | -6.07 ± 8.91 Hot Flashes per day |
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| p-value | < 0.0001 |
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| Least squares (LS) means | -3.04 (95% CI -4.40–-1.68) |
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Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD)
From baseline to Week 12 · Hot flashes per day
| Elinzanetant 120 mg | 14.66 ± 11.08 Hot flashes per day |
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| Placebo - Elinzanetant 120 mg | 16.16 ± 11.15 Hot flashes per day |
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| Elinzanetant 120 mg | -9.96 ± 10.25 Hot flashes per day |
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| Placebo - Elinzanetant 120 mg | -7.24 ± 8.49 Hot flashes per day |
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| p-value | < 0.0001 |
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| LS-means | -3.24 (95% CI -4.60–-1.88) |
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Mean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD)
From baseline to Week 4 · Units on a scale
| Elinzanetant 120 mg | 2.53 ± 0.24 Units on a scale |
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| Placebo - Elinzanetant 120 mg | 2.54 ± 0.24 Units on a scale |
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| Elinzanetant 120 mg | -0.75 ± 0.68 Units on a scale |
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| Placebo - Elinzanetant 120 mg | -0.53 ± 0.55 Units on a scale |
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| p-value | 0.0003 |
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| LS-means | -0.22 (95% CI -0.34–-0.09) |
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