Completed

OASIS-3Elinzanetant for Hot Flashes in Postmenopausal Women

Study Aim

This phase 3 study aims to evaluate whether elinzanetant can reduce the frequency and severity of hot flashes in postmenopausal women over a 12-week period.

What is being tested

Elinzanetant (BAY3427080)

+ Placebo

Drug

Who is being recruted

Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

+ Hot Flashes

From 40 to 65 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: August 2021

See protocol details

Summary

Principal SponsorBayer

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 27, 2021

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding a more effective treatment for postmenopausal women experiencing hot flashes, a common symptom during menopause caused by hormonal changes. Menopause marks the end of a woman's menstrual cycles and is accompanied by a decrease in hormone production, leading to symptoms that can significantly affect quality of life. The study is investigating a new treatment called elinzanetant, which aims to alleviate hot flashes by blocking a protein involved in triggering them. Current treatments can sometimes lead to medical issues, so finding a safer alternative is important for improving comfort and health in postmenopausal women. Participants in this study will take two capsules of either elinzanetant or a placebo once daily for 52 weeks. A placebo is a substance with no active medicine, used to compare the effects of the actual drug. The effectiveness of elinzanetant will be measured by tracking changes in the frequency and severity of hot flashes over a 12-week period, as recorded in an electronic diary. Besides recording their symptoms, participants will answer questions about their overall experience and undergo regular health checks, including blood tests, across approximately 62 weeks. The study includes 11 in-person visits and 2 phone consultations, ensuring thorough monitoring for any medical issues that may arise.

Official TitleA Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 52 Weeks in Postmenopausal Women

NCT05030584

Principal SponsorBayer

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

628 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 40 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Signs and SymptomsPathological Conditions, Signs and SymptomsHot Flashes

Criteria

3 inclusion criteria required to participate

Postmenopausal, defined as: 1. at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or 2. at least 6 months of spontaneous amenorrhea prior to signing of informed consent with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or 3. at least 6 months after hysterectomy at signing of informed consent with serum FSH levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or 4. surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to signing of informed consent.

Moderate to severe hot flash (HF) associated with the menopause and seeking treatment for this condition.

Participant has completed Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks preceding baseline visit and is showing eligibility with respect to previous inclusion criterion during this time period.

9 exclusion criteria prevent from participating

Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on ECG evaluation.

Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms (VMS) such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome.

Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors). Women receiving adjuvant endocrine therapy (e.g. tamoxifen, aromatase inhibitors, GnRH analogues) cannot be enrolled in this study.

Uncontrolled or treatment-resistant hypertension. Women with mild hypertension can be included in the study if they are medically cleared prior to study participation.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Participants will receive 120 mg elinzanetant orally once daily.

Group II

Placebo

Participants will receive matching placebo orally once daily.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 86 locations

Suspended

Mobile ObGyn, P.C. | Mobile, AL

Mobile, United StatesOpen Mobile ObGyn, P.C. | Mobile, AL in Google Maps

Suspended

Mesa Obstetricians and Gynecologists | Research Department

Mesa, United States

Suspended

National Institute of Clinical Research - Garden Grove

Garden Grove, United States

Suspended

Marvel Clinical Research | Huntington Beach, CA

Huntington Beach, United States

Completed86 Study Centers