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)
Condition: Vasomotor Symptoms Associated With Menopause · Hot Flashes · Sponsor: Bayer
About this study
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 r…
This description comes directly from the study's public registry record.
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Locations (113)
| Accel Research Sites | Cahaba Medical Care - Birmingham, AL | Birmingham, Alabama, United States | — |
| Women's Health Alliance of Mobile | Mobile, Alabama, United States | — |
| Onyx Clinical Research - Peoria | Peoria, Arizona, United States | — |
| Lynn Institute of the Ozarks | Little Rock, Arkansas, United States | — |
| National Institute of Clinical Research - Garden Grove | Garden Grove, California, United States | — |
| Clinical Trials Research - Lincoln | Lincoln, California, United States | — |
| Torrance Clinical Research Institute, Inc. | Lomita, CA | Lomita, California, United States | — |
| Women's Health Care Research | San Diego, CA | San Diego, California, United States | — |
| Advanced Women's Health Institute | Denver Office, Greenwood Village, CO | Greenwood Village, Colorado, United States | — |
| Physicians' Research Options, LLC | Red Rocks OBGYN | Lakewood, Colorado, United States | — |
| Helix Biomedics, LLC | Boynton Beach, Florida, United States | — |
| Clinical Research of West Florida | Clearwater, FL | Clearwater, Florida, United States | — |
+ 101 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05099159