← Back to Search

Hormone Therapy

Elinzanetant for Menopausal Sleep Disturbances (NIRVANA Trial)

Phase 2
Recruiting
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females aged 40 to 65 years, inclusive, at signing of informed consent
Being in the post-menopausal period, defined as: serum FSH levels >40 mIU/mL and a serum estradiol concentration of <30 pg/mL at screening, AND Hysterectomy performed at least 6 weeks prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights

NIRVANA Trial Summary

This trial will investigate a potential new treatment to help women with sleep disturbances associated with menopause. Researchers will analyze how the treatment affects sleep quality. Participants will take elinzanetant or placebo for 12 weeks and have 5 visits to the study site.

Who is the study for?
This trial is for women aged 40-65 who are post-menopausal, experiencing sleep disturbances like waking up at night. They must have a specific level of hormone showing they're in menopause and can't join if they have other sleep disorders, a history of cancer (except certain skin cancers), or moderate to severe kidney problems.Check my eligibility
What is being tested?
The study tests Elinzanetant against a placebo to see if it helps with menopausal sleep issues. Women will be randomly assigned to either the drug or placebo for 12 weeks and monitored through visits, blood/urine tests, physical exams, vital checks, and home-recorded sleep quality.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally include any new medical problems that arise during the trial. Doctors will track all health changes whether or not they believe these are related to the treatment.

NIRVANA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged between 40 and 65.
Select...
I am post-menopausal with specific hormone levels and had a hysterectomy at least 6 weeks ago.

NIRVANA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change from baseline in ISI total score
Change from baseline in PROMIS SD SF 8b total score
Change from baseline in SE as measured by PSG
+3 more

NIRVANA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Elinzanetant armExperimental Treatment1 Intervention
Participants will take Elinzanetant
Group II: Placebo armPlacebo Group1 Intervention
Participants will take elinzanetant matching placebo

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,240 Previous Clinical Trials
25,332,699 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this medical experiment open to octogenarians?

"As specified by the trial's requirements, qualified participants must be between 40 and 65 years old."

Answered by AI

What assurances can be given to individuals regarding the safety of Elinzanetant arm?

"As Elinzanetant arm is currently in Phase 2 trials, we have assigned it a safety score of 2 due to some evidence suggesting its security but no proof yet corroborating efficacy."

Answered by AI

Am I eligible to be a volunteer for this medical experiment?

"This medical trial will accept applications from menopausal individuals aged between 40 and 65 who experience sleep disturbances. A maximum of 78 patients can be enrolled in total."

Answered by AI

How many healthcare facilities are presently engaged in this research endeavor?

"This medical trial is being conducted at Santa Monica Clinical Trials Los Angeles in Los Angeles, California, Pacific Research Network in San Diego, Florida and Pacific Clinical Research Management Group LLC in Upland, Georgia along with 57 other sites."

Answered by AI

Is there currently an effort to bring new participants into this research?

"This trial, initially posted on November 6th 2023 and most recently updated on October 27th , is not actively recruiting patients. Nevertheless, there are 124 other studies that are currently looking for volunteers."

Answered by AI

Who else is applying?

What site did they apply to?
Pacific Research Network
PharmaDev Clinical Research Institute, LLC
NEUROTRIALS RESEARCH INC Atlanta
Other
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
2023. "A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06112756.
All > Paid Studies Las Vegas > Menopause
~35 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top