A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause (NIRVANA)

Bayer

Status and phase: Completed; Phase 2

Conditions: Sleep Disturbances Associated With Menopause

Treatments: Other: Placebo; Drug: Elinzanetant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06112756

2023-504955-28-00 (Other Identifier)

22423

Details and patient eligibility

About

Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause.

Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, for example, frequent waking up at night, are a common and bothersome symptom associated with menopause that affects women's quality of life.

The study treatment Elinzanetant (also called BAY 3427080) is under development to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause. It may block the activity of a protein that has been found to contribute to sleep disturbances.

The main purpose of this study is to learn how does elinzanetant affect sleep disturbances associated with menopause as measured on a sleep test called polysomnography (PSG) as compared with placebo.

For this, the researchers will analyze

• change in the total number of minutes a participant wakes up at night after going to sleep after 4 weeks of treatment compared to before treatment
• change in the total number of minutes a participant wakes up at night after going to sleep after 12 weeks of treatment compared to before treatment
• change in the participant's total time asleep while in bed after 4 and 12 weeks of treatment compared to before treatment.

The study participants will be randomly (by chance) assigned to one of two treatment groups. Dependent on the group, they will take elinzanetant or placebo for 12 weeks.

Each participant will be in the study for approximately 22 weeks (plus potential washout period), including a screening phase of up to 6 weeks, 12 weeks of treatment, and a follow up phase of 4 weeks after the end of treatment. 5 visits to the study site are planned.

During the study, the doctors and their study team will:

• take blood and urine samples
• do physical examinations
• check vital signs
• do sleep tests
• use an electronic hand-held device to record sleep quality and hot flashes at home

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Enrollment: 110 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• The participant's self-reported sleep history includes ongoing sleep disturbances associated with menopause characterized by waking up at night and/or poor quality of sleep.
• WASO of 30 minutes or more (mean of 2 screening PSGs with neither of the 2 nights <20 min).

Exclusion criteria

• Medical history, or baseline PSG assessment, includes a diagnosis of a sleep disorder other than sleep disturbances associated with the menopause (e.g., sleep apnea, restless leg syndrome, circadian rhythm sleep disorder).
• Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors).
• Renal impairment greater than moderate (i.e. estimated glomerular filtration rate <30 mL/min/1.73 m^2) at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

Elinzanetant arm

Experimental group

Description:

Participants will take Elinzanetant

Treatment:

Drug: Elinzanetant

Placebo arm

Placebo Comparator group

Description:

Participants will take elinzanetant matching placebo

Treatment:

Other: Placebo