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

Conditions

• Hot Flashes
• Vasomotor Symptoms Associated With Menopause

Eligibility Criteria

Sex

FEMALE

Age

40 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Elinzanetant (BAY3427080) — DRUG
  120 mg elinzanetant orally once daily
• Placebo — DRUG
  Matching placebo orally once daily.

Study Details

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.

Key Dates

First listed

Sep 1, 2021

Start date

Aug 27, 2021

Status verified

Nov 2025

Primary completion

Mar 29, 2023

Completion

Feb 12, 2024

Study Design

Enrollment

628 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Elinzanetant (BAY3427080)
  Participants will receive 120 mg elinzanetant orally once daily.
• Placebo Comparator: Placebo
  Participants will receive matching placebo orally once daily.

Primary Outcome Measure

Mean Change in Frequency of Moderate to Severe Hot Flashes (HFs) From Baseline to Week 12 (Assessed by Hot Flash Daily Diary [HFDD]) [ Time Frame: Baseline to Week 12 ]

Locations (36)

Find similar trials in Mobile, AL

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