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A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause

NCT05030584 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 628

Last updated 2025-12-01

Study results available
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Summary

Researchers are looking for a better way to treat women who have hot flashes after they have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life.

The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people.

In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To compare these study treatments, the participants will record information about their hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe they are. They will study the results from before treatment and after 12 weeks of treatment.

The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants will take the study treatments for 52 weeks.

During the study, the participants will visit their study site approximately 11 times and perform 2 visits by phone. Each participant will be in the study for approximately 62 weeks.

During the study, the participants will:

* record information about their hot flashes in an electronic diary
* answer questions about their symptoms

The doctors will:

* check the participants' health
* take blood samples
* ask the participants questions about what medicines they are taking and if they are having adverse events An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

Conditions

  • Vasomotor Symptoms Associated With Menopause
  • Hot Flashes

Interventions

DRUG

Elinzanetant (BAY3427080)

120 mg elinzanetant orally once daily

DRUG

Placebo

Matching placebo orally once daily.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2023-03-29
Completion
2024-02-12
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • Denmark
  • Finland
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05030584 on ClinicalTrials.gov