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 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)

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 women 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 looks like a treatment but does not have any medicine in it. To compare these study treatments, the doctors will ask the participants to record information about the participants' hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe the hot flashes are. The researchers will look at the results from before treatment, after 4 weeks, 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 who take elinzanetant will take it for 26 weeks. The participants who take the placebo will take it for 12 weeks and then take elinzanetant for the next 14 weeks. During the study, the participants will visit the site approximately 9 times and perform 1 visit by phone. Each participant will be in the study for approximately 36 weeks. The treatment duration will be 26 weeks. During the study, the participants will: * record information about the participants' hot flashes in an electronic diary * answer questions about the participants' symptoms The doctors will: * check the participants' health * take blood samples * ask the participants questions about what medicines the participants are taking and if the participants 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 doctors do not think the adverse events might be related to the study treatments.

Key Dates

First listed

Oct 29, 2021

Start date

Oct 29, 2021

Status verified

Jan 2026

Primary completion

Jun 13, 2023

Completion

Oct 10, 2023

Study Design

Enrollment

400 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Elinzanetant (BAY3427080)
  Participants will receive 120 mg elinzanetant orally once daily for 26 weeks.
• Placebo Comparator: Placebo + elinzanetant
  Participants will receive matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks.

Primary Outcome Measure

Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD) [ Time Frame: From baseline to Week 4 ]

Locations (48)

Find similar trials in Birmingham, AL

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