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Elinzanetant (BAY3427080) for Hot Flashes

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Signature GYN Services, Pllc, Fort Worth, TXHot Flashes+1 MoreElinzanetant (BAY3427080) - Drug
Eligibility
40 - 65
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Hot Flashes

Video Summary

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
PRP
1
Orvepitant Maleate
1
ACER-801 50 mg BID

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: Baseline to Week 26

Baseline to Week 1
Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)
Baseline to Week 12
Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12
Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
Body Weight Changes
Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12
Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
Baseline to Week 26
Mean change in BDI-II total score from baseline to Week 26
Mean change in frequency of moderate to severe HF from baseline over time
Baseline to Week 4
Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])
Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
PRP
2
Orvepitant Maleate
1
ACER-801 50 mg BID

Side Effects for

160 mg Elinzanetant (BAY3427080)
12%Somnolence
8%Headache
8%Fatigue
6%Diarrhoea
6%Dizziness
4%Urinary tract infection
4%Nausea
4%Oropharyngeal pain
2%Blood creatine phosphokinase increased
2%Tooth abscess
2%Rash
2%Insomnia
2%Arthropod bite
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03596762) in the 160 mg Elinzanetant (BAY3427080) ARM group. Side effects include: Somnolence with 12%, Headache with 8%, Fatigue with 8%, Diarrhoea with 6%, Dizziness with 6%.

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

Elinzanetant (BAY3427080)
Drug
Experimental Group · 1 Intervention: Elinzanetant (BAY3427080) · Intervention Types: Drug
Placebo + elinzanetantPlaceboComparator Group · 2 Interventions: Elinzanetant (BAY3427080), Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elinzanetant (BAY3427080)
2022
Completed Phase 2
~400

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 26

Who is running the clinical trial?

BayerLead Sponsor
2,159 Previous Clinical Trials
23,877,144 Total Patients Enrolled
12 Trials studying Hot Flashes
3,046 Patients Enrolled for Hot Flashes

Eligibility Criteria

Age 40 - 65 · Female Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are experiencing intense hot flashes due to menopause and are actively seeking treatment for it.

Who else is applying?

What state do they live in?
Texas52.9%
Alabama17.6%
New York11.8%
Other17.6%
How old are they?
18 - 65100.0%
What site did they apply to?
Accel Research Sites - Cahaba Medical Care28.6%
Womens Health Care Research Corporation14.3%
University of Chicago14.3%
Other42.9%
What portion of applicants met pre-screening criteria?
Did not meet criteria33.3%
Met criteria66.7%
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?
025.0%
125.0%
225.0%
3+25.0%

How responsive is this trial?

Most responsive sites:
  1. Columbia University Medical Center: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email100.0%
References

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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