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NCT05042362 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 396
- Enrollment target
NCT05042362 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 396 participants.
The verdict
NCT05042362, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 396 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Elinzanetant (BAY3427080)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2021-08-27 |
| Est. Completion | 2023-11-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05042362
The ClinicalTrials.gov registry entry for NCT05042362 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 396 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05042362 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05042362 about?
NCT05042362 is a clinical study titled "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". 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 ...
What is the current status of trial NCT05042362?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 396 participants. The study started on 2021-08-27. Estimated completion is 2023-11-27.
What interventions are being tested in trial NCT05042362?
The interventions under investigation include: Placebo (DRUG), Elinzanetant (BAY3427080) (DRUG).
Who is sponsoring clinical trial NCT05042362?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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