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

A double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 26 weeks in postmenopausal women - OASIS 2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004855-34-PT

Enrollment

370

Registered

2021-11-03

Start date

2022-01-27

Completion date

Unknown

Last updated

2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasomotor symptoms associated with menopause MedDRA version: 21.1 Level: LLT Classification code 10050903 Term: Postmenopausal symptoms System Organ Class: 100000004872

Interventions

Product Name: BAY 3427080 SOFT CAPS 60 MG 001 Product Code: BAY 3427080 (formerly NT-814) Pharmaceutical Form: Capsule, soft INN or Proposed INN: Elinzanetant CAS Number: 929046-33-3 Current Sponsor c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Females aged 40 to 65 years, inclusive, at signing of informed consent. 2. Postmenopausal, defined as: a. at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or b. 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 40 mIU/mL and a serum estradiol concentration of =65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

Exclusion criteria: 1. Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on ECG evaluation. 2. Any clinically significant abnormal laboratory test result(s) measured during screening (single re-test allowed, except for tests listed in exclusion criteria 10). 3. Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms (VMS) such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome. 4. Current or previous history of any malignancy (except basal and squamous cell skin tumors). 5. Uncontrolled or treatment-resistant hypertension. Women with mild hypertension can be included in the study if they are medically cleared prior to study participation. 6. A history of untreated hyperthyroidism or hypothyroidism. Treated hypothyroidism with normal thyroid function test results during screening and a stable (for >= 3 months before signing of informed consent) dose of replacement therapy is acceptable. 7. Any unexplained post-menopausal bleeding. 8. Clinically relevant abnormal findings on mammogram. 9. Renal impairment greater than moderate (i.e. estimated glomerular filtration rate < 30 mL/min) at screening 10. Abnormal liver parameters. 11. Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening. 12. Any other history, condition, therapy, or uncontrolled intercurrent illness which could in the opinion of the investigator affect compliance with study requirements. 13. Has used and is unwilling to wash-out use of any of the prohibited concomitant medications. 14. Inability to comply with the use of prohibited medications.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of elinzanetant for the treatment of vasomotor symptoms (VMS) associated with the menopause.;Secondary Objective: 1. To evaluate the onset of efficacy of elinzanetant for the treatment of VMS associated with the menopause. 2. To evaluate the efficacy of elinzanetant in women treated for relief of VMS associated with the menopause on: sleep quality; menopause related quality of life; depressive symptoms. 3. To evaluate the safety of elinzanetant for the treatment of VMS associated with the menopause.;Primary end point(s): 1. Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD]). 2. Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD).;Timepoint(s) of evaluation of this end point: 1. Baseline to Week 4. 2. Baseline to Week 12.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of elinzanetant for the treatment of vasomotor symptoms (VMS) associated with the menopause.;Secondary Objective: 1. To evaluate the onset of efficacy of elinzanetant for the treatment of VMS associated with the menopause. 2. To evaluate the efficacy of elinzanetant in women treated for relief of VMS associated with the menopause on: sleep quality; menopause related quality of life; depressive symptoms. 3. To evaluate the safety of elinzanetant for the treatment of VMS associated with the menopause.;Primary end point(s): 1. Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD]). 2. Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD).;Timepoint(s) of evaluation of this end point: 1. Baseline to Week 4. 2. Baseline to Week 12.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD). 2. Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD). 3. Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD). 4. Mean change in frequency of moderate to severe HF from baseline over time. 5. Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12. 6. Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12. 7. Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12. 8. Mean change in BDI-II total score from baseline to Week 26.;Timepoint(s) of evaluation of this end point: 1. Baseline to Week 4. 2. Baseline to Week 12. 3. Baseline to Week 1. 4. Baseline to end of trial. 5. Baseline to Week 12. 6. Baseline to Week 12. 7. Baseline to Week 12. 8. Baseline to Week 26.	—

Measure

Time frame

Secondary end point(s): 1. Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD). 2. Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD). 3. Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD). 4. Mean change in frequency of moderate to severe HF from baseline over time. 5. Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12. 6. Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12. 7. Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12. 8. Mean change in BDI-II total score from baseline to Week 26.;Timepoint(s) of evaluation of this end point: 1. Baseline to Week 4. 2. Baseline to Week 12. 3. Baseline to Week 1. 4. Baseline to end of trial. 5. Baseline to Week 12. 6. Baseline to Week 12. 7. Baseline to Week 12. 8. Baseline to Week 26.

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Countries

Canada, Czech Republic, Germany, Italy, Norway, Poland, Portugal, Russian Federation, Slovakia, Switzerland, Ukraine, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trials-contact@bayer.com+493030013 9003

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026