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Elinzanetant (BAY3427080) for Hot Flashes

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Northeast Clinical Research of San Antonio, LLC, San Antonio, TXHot Flashes+1 MoreElinzanetant (BAY3427080) - Drug
Eligibility
40 - 65
Female
What conditions do you have?
Select

Study Summary

This trial is studying a better way to treat women who have hot flashes after menopause.

Eligible Conditions
  • Hot Flashes

Treatment Effectiveness

Effectiveness Progress

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

Similar Trials

1
Orvepitant Maleate
1
ACER-801 50 mg BID
1
FP-101

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)
Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12
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

2
Orvepitant Maleate
1
ACER-801 50 mg BID
2
FP-101

Side Effects for

40 mg Elinzanetant (BAY3427080)
10%Headache
10%Somnolence
10%Fatigue
6%Oropharyngeal pain
6%Urinary tract infection
6%Nausea
6%Arthropod bite
6%Diarrhoea
3%Nasopharyngitis
3%Blood creatine phosphokinase increased
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03596762) in the 40 mg Elinzanetant (BAY3427080) ARM group. Side effects include: Headache with 10%, Somnolence with 10%, Fatigue with 10%, Oropharyngeal pain with 6%, Urinary tract infection 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
2,158 Previous Clinical Trials
23,877,251 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 moderate to severe menopause-related hot flashes and want treatment for them.

Who else is applying?

What state do they live in?
Texas42.9%
Alabama14.3%
Nevada14.3%
Other28.6%
How old are they?
18 - 65100.0%
What site did they apply to?
St. Vincent's Hospital - Birmingham20.0%
Soapstone Center for Clinical Research20.0%
Houston Center for Clinical Research, LLC40.0%
Other20.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria28.6%
Met criteria71.4%
References

Frequently Asked Questions

How many research facilities are in charge of this experiment?

"Among other locations, this study is occurring at Essential Women's Health Associates in Las Vegas, Nevada, Investigators Research Group, LLC in Brownsburg, Indiana, and Maximos Ob/Gyn in League City, Texas." - Anonymous Online Contributor

Unverified Answer

How can I enroll myself in this research project?

"This trial is looking for 370 patients that are experiencing hot flashes and are between 40-65 years old. Additionally, the potential participants must have completed the Hot Flash Daily Diary for at least 11 days in the two weeks before the baseline visit. They must also have recorded at least 50 moderate or severe hot flashes in the last 7 days of the HFDD." - Anonymous Online Contributor

Unverified Answer

Are people still being taken on as participants for this research project?

"Yes, the data on clinicaltrials.gov indicates that this study is actively searching for candidates. The trial was initially posted on 8/27/2021 and was last updated on 10/31/2022. The study is searching for 370 patients at 58 locations." - Anonymous Online Contributor

Unverified Answer

Are elderly patients being accepted for this clinical trial?

"The minimum age requirement for this study is 40 years old and the maximum is 65 years old." - Anonymous Online Contributor

Unverified Answer

What kind of health risks are associated with taking Elinzanetant?

"Elinzanetant (BAY3427080) is in Phase 3 of clinical trials, which means that there is both some efficacy data and multiple rounds of safety data. Therefore, it received a score of 3." - 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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