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)

Recruiting at 134 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Bayer

Must not be taking: Adjuvant endocrine therapy

Disqualifiers: Arrhythmias, Malignancy, Hypertension, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 26 weeks

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called elinzanetant to help women who have hot flashes after menopause. The medication works by blocking signals that cause hot flashes. Researchers will track the number and severity of hot flashes over time.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, the doctors will ask about the medicines you are taking, so it's best to discuss your specific situation with them.

Eligibility Criteria

Inclusion Criteria

at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or 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 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 surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to signing of informed consent.

Postmenopausal, defined as:

Participant has completed Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks preceding baseline visit, and participant has recorded at least 50 moderate or severe HF (including night-time HF) over the last 7 days that the HFDD was completed (assessed at the Baseline Visit).

Exclusion Criteria

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

Untreated hyperthyroidism or hypothyroidism.

Treated hyperthyroidism with no abnormal increase of thyroid function laboratory parameters and no relevant clinical signs for > 6 months before signing of informed consent is acceptable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either elinzanetant or placebo for 26 weeks. Placebo group switches to elinzanetant after 12 weeks.

26 weeks

9 visits (in-person), 1 visit (phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Elinzanetant

Participant Groups

Group I: Elinzanetant (BAY3427080) Experimental Treatment 1 Intervention

Participants will receive 120 mg elinzanetant orally once daily for 26 weeks.

Group II: Placebo + elinzanetant Placebo Group 2 Interventions

Participants will receive matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks.

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

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Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD