What side effects are associated with this type of intervention?

Common treatments for menopausal sleep disturbances include neurokinin receptor antagonists and menopausal hormone therapy (MHT). Neurokinin receptor antagonists, like Elinzanetant, may cause side effects such as headaches, elevated liver function tests, and abnormal dreams. Menopausal hormone therapy, which includes estrogen and progestin, can lead to side effects such as an increased risk of coronary heart disease, invasive breast cancer, stroke, and pulmonary embolism. However, it may also reduce the risk of colorectal cancer and hip fractures. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

There are currently no specific FDA-approved drugs that target menopausal sleep disturbances by blocking the activity of proteins contributing to these issues, similar to the investigational drug Elinzanetant. However, treatments for menopausal symptoms, including sleep disturbances, often involve hormone replacement therapy (HRT) and other medications like selective serotonin reuptake inhibitors (SSRIs) and gabapentin, which can help alleviate hot flashes and improve sleep quality. These treatments address the broader spectrum of menopausal symptoms rather than targeting specific proteins involved in sleep disturbances.

What other types of research exist?

Promising alternatives to Elinzanetant for menopausal sleep disturbances include hormone replacement therapy (HRT) with estrogen or combined estrogen-progestin, which can alleviate symptoms like hot flashes that disrupt sleep. Additionally, selective serotonin reuptake inhibitors (SSRIs) such as sertraline have been studied for their effectiveness in managing hot flashes and associated sleep disturbances. Non-pharmacological options like cognitive-behavioral therapy for insomnia (CBT-I) and lifestyle modifications (e.g., sleep hygiene, relaxation techniques) are also viable alternatives.

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Hormone Therapy

Elinzanetant for Menopausal Sleep Disturbances (NIRVANA Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for menopausal sleep disturbances often target the hormonal changes that disrupt sleep. Elinzanetant, for instance, blocks the activity of a protein that contributes to these disturbances. Similar treatments, like neurokinin 3 receptor antagonists, modulate specific proteins involved in hot flashes and sleep issues. These mechanisms are important for menopausal patients as they address the root causes of their symptoms, potentially offering more effective and personalized relief.

Phase 2

Waitlist Available

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

Must not have

Renal impairment greater than moderate (i.e. estimated glomerular filtration rate <30 mL/min/1.73 m^2) at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 12

Summary

This trial is testing a new medication called Elinzanetant to help women who have trouble sleeping due to menopause. The medication may help by blocking a protein that causes sleep problems. Participants will take the medication for a few months to see if it improves their sleep.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in WASO as measured by PSG

Secondary study objectives

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

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for menopausal sleep disturbances often target the hormonal changes that disrupt sleep. Elinzanetant, for instance, blocks the activity of a protein that contributes to these disturbances. Similar treatments, like neurokinin 3 receptor antagonists, modulate specific proteins involved in hot flashes and sleep issues. These mechanisms are important for menopausal patients as they address the root causes of their symptoms, potentially offering more effective and personalized relief.

[Estrogen therapy in climacteric. Current views in an evidence-based perspective].