An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States

NCT07490431 | Not Yet Recruiting FDA Drug

• 1 other identifier: 22958
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Menopause is a natural stage in a woman's life happening between ages 45 and 55. It is often associated with disruptive symptoms like hot flashes and sleep disturbances that can affect up to 8 out of 10 women and make daily life harder. Elinzanetant is a new, hormone free medicine that works by blocking certain signals in the brain that are linked to these symptoms. It has already been shown in clinical studies to help reduce hot flashes. This study is being done to learn about how elinzanetant is used, how well it works, and how safe it is for women with menopause symptoms in real-world, everyday medical care. The main goal is to understand who is starting treatment with elinzanetant and what symptoms they have. The study will also look at how well elinzanetant helps with hot flashes, night sweats, and sleep problems, how safe it is, how satisfied women are with the treatment, and how it affects their quality of life and daily activities. To do this, researchers will follow about 1,500 women in the United States who are starting elinzanetant as part of their usual care. Women will answer questions about their symptoms, sleep, and daily life using a secure app on their phone or computer. Some women will also wear a smart ring for a few weeks to collect information about their sleep. The study will last about 12 weeks for most women, but some will be followed for up to 2 years. No extra treatments or tests will be given as part of the study-researchers will only collect information about how women are doing while taking elinzanetant as prescribed by their own doctor. The results will help doctors and patients understand how elinzanetant works in real life and support better care for women going through menopause.

Conditions

Vasomotor Symptoms (VMS) Associated With Menopause

Outcome Measures

Primary Outcomes (7)

• Socio-demographic characteristics

  Day 1

• Menopausal status

  Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early/premature menopause.

  Day 1

• Time since menopause onset and time since onset of menopausal symptoms

  Day 1

• Descriptive analyses of prior vasomotor symptoms (VMS) related clinical history

  Day 1

• Menopausal symptoms measured by MENQOL

  MENQOL: Menopause-Specific Quality of Life Questionnaire. It contains 29 items questionnaire that assess presence of menopausal symptoms and how bothersome they are, across four domains: vasomotor, psychosocial, physical and sexual. For each item, the participant indicates if they have experienced the symptom (yes/no). If participants select yes, participants rate how bothered they were by the symptom using a scale with response options ranging from 0 'not at all bothered' to 6 'extremely bothered'. Based on the individual responses, item scores, domain scores, and a total MENQOL score are calculated. Each score ranges from 1-8, higher scores indicate greater bother.

  Day 1, week 4,12 and when applicable at week 24, 52, 104

• Height

  Day 1, week 4 and week 12

• Weight

  Day 1, week 4 and week 12

Secondary Outcomes (12)

• Change in VMS from the baseline period to week 4 and 12

  Week 4 and 12

• Change in sleep disturbances measured by PROMIS-SD-SF-8b questionnaire

  Week 4, 12 and when applicable week 24, 52 and 104

• Number of SAE and serious TEAE

  From Day 1 to week 12 or week 104 when applicable

• HCP reasons for prescribing elinzanetant

  Day 1

• Participants' satisfaction with treatment for symptoms associated with menopause

  Week 12 and week 52 when applicable

Study Arms (1)

Group 1

Elizanetant users

Other: No intervention

Interventions

No intervention OTHER

The study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care

Group 1

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women in the US who are newly initiating treatment with elizanetant

You may qualify if:

• Women who newly initiate elinzanetant for treatment of menopausal VMS according to the current local label.
• Signed ICF.
• Ability and willingness to use study-related digital tools and to complete electronic questionnaires (ePROs), requiring access to an internet-connected device.

You may not qualify if:

• Participation in an investigational trial with interventions outside of routine clinical practice.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer

Whippany, New Jersey, 07981, United States

Location

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 24, 2026
• Study Start (Estimated): November 2, 2026
• Primary Completion (Estimated): November 2, 2029
• Study Completion (Estimated): November 2, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)