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NCT06112756 · ClinicalTrials.gov registry record · Phase 2
A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
NCT06112756 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 110 participants.
The verdict
NCT06112756, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause. Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, for example, frequent waking up at night, are a common and bothersome symptom associated with menopause that affects women's quality of life. The study treatment Elinzanetant (also called BAY 3427080) is under development to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause. It may block the activity of a protein that has been found to contribute to sleep disturbances. The main purpose of this study is to learn how does elinzanetant affect sleep disturbances associated with menopause as measured on a sleep test called polysomnography (PSG) as compared with placebo. For this, the researchers will analyze * change in the total number of minutes a participant wakes up at night after going to sleep after 4 weeks of treatment compared to before treatment * change in the total number of minutes a participant wakes up at night after going to sleep after 12 weeks of treatment compared to before treatment * change in the participant's total time asleep while in bed after 4 and 12 weeks of treatment compared to before treatment. The study participants will be randomly (by chance) assigned to one of two treatment groups. Dependent on the group, they will take elinzanetant or placebo for 12 weeks. Each participant will be in the study for approximately 22 weeks (plus potential washout period), including a screening phase of up to 6 weeks, 12 weeks of treatment, and a follow up phase of 4 weeks after the end of treatment. 5 visits to the study site are planned. During the study, the doctors and their study team will: * take blood and urine samples * do physical examinations * check vital signs * do sleep tests * use an electronic hand-held device to record sleep quality and hot flashe
Interventions
- OTHER Placebo
- DRUG Elinzanetant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2023-11-08 |
| Est. Completion | 2024-11-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06112756
The ClinicalTrials.gov registry entry for NCT06112756 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 110 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.
NCT06112756 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06112756 about?
NCT06112756 is a clinical study titled "A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause". Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause. Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, for example, frequent waking up at night, are a commo...
What is the current status of trial NCT06112756?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2023-11-08. Estimated completion is 2024-11-07.
What interventions are being tested in trial NCT06112756?
The interventions under investigation include: Placebo (OTHER), Elinzanetant (DRUG).
Who is sponsoring clinical trial NCT06112756?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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