Study Summary
This trial is looking for a better way to treat women who have hot flashes after going through menopause. Elinzanetant is a new treatment that blocks a protein called neurokinin from sending signals to other parts of the body. The study will compare elinzanetant to a placebo in women who have been through the menopause and have hot flashes.
- Hot Flashes
Video Summary
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 6 Secondary · Reporting Duration: Baseline to Week 26
Trial Safety
Safety Progress
Side Effects for
Trial Design
2 Treatment Groups
Elinzanetant (BAY3427080)
1 of 2
Placebo + elinzanetant
1 of 2
Experimental Treatment
Non-Treatment Group
370 Total Participants · 2 Treatment Groups
Primary Treatment: Elinzanetant (BAY3427080) · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 40 - 65 · Female Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
Texas | 52.9% |
Alabama | 17.6% |
New York | 11.8% |
Other | 17.6% |
How old are they?
18 - 65 | 100.0% |
What site did they apply to?
Accel Research Sites - Cahaba Medical Care | 28.6% |
Womens Health Care Research Corporation | 14.3% |
University of Chicago | 14.3% |
Other | 42.9% |
What portion of applicants met pre-screening criteria?
Did not meet criteria | 33.3% |
Met criteria | 66.7% |
Why did patients apply to this trial?
- "I had a hysterectomy at age 38 with removal of one ovary. I was put on HRT but had to stop as I am now 73. And I now have hot flashes a few times a day. Zoloft has been tried but is not very effective."
- "Tired of my doctors telling me that hot flashes are normal and that we basically have to deal with them! I don’t feel normal being that I don’t have a *** drive at all. Brain fog is terrible! A friend told me about these studies and I suddenly felt some hope in this rollercoaster ride of hot flashes…"
What questions have other patients asked about this trial?
- "How long do screenings visits take?"
How many prior treatments have patients received?
0 | 25.0% |
1 | 25.0% |
2 | 25.0% |
3+ | 25.0% |
How responsive is this trial?
Most responsive sites:
- Columbia University Medical Center: < 48 hours
Average response time
- < 2 Days
Typically responds via
100.0% | |
Frequently Asked Questions
How does Elinzanetant (BAY3427080) affect patients negatively?
"There is available clinical data that supports the safety of Elinzanetant (BAY3427080), so it received a score of 3." - Anonymous Online Contributor
Are we still enrolling people for this research project?
"Yes, this study is still looking for participants. The listing on clinicaltrials.gov says that the trial was first posted on 2021-10-29 and updated on 31 October, 2022." - Anonymous Online Contributor
Are there many hospitals participating in this research project in our state?
"At the moment, this clinical trial is being conducted at 61 different facilities. Some of the places where this trial is taking place include Garden Grove, Houston and Sherbrooke. If you are interested in participating, try to choose a location near you to reduce travel time and expenses." - Anonymous Online Contributor
Could patients who are 18 years or older participate in this clinical trial?
"This study's age limit is between 40-65 years old." - Anonymous Online Contributor
Am I eligible to help with this research?
"Up to 370 individuals aged between 40 and 65 that are experiencing hot flashes may be admitted into this clinical trial. The main criteria that applicants must meet are as follows: they must have undergone at least 12 months of spontaneous amenorrhea before signing the informed consent form, or have had at least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels of over 40 mIU/mL and a serum estradiol concentration of under 30 pg/mL, or have had at least 6 months after a hysterectomy at signing of informed consent with serum FSH levels of over 40 mIU" - Anonymous Online Contributor
How many people total are allowed to sign up for this research project?
"To begin the trial, 370 patients who meet the eligibility requirements must be enrolled. These patients can come from various locations, such as National Institute of Clinical Research - Garden Grove in Garden Grove, California and UT Health Women's Research Center at Memorial City in Houston, Texas." - Anonymous Online Contributor