Skip to content

A double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms caused by adjuvant endocrine therapy, over 52 weeks and optionally for additional up to 3.5 years in women with, or at high risk for developing hormone-receptor positive breast cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508265-33-00
Acronym
21656
Enrollment
417
Registered
2024-02-20
Start date
2022-10-13
Completion date
Unknown
Last updated
2026-01-20

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

Conditions

Vasomotor symptoms caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone-receptor positive breast cancer

Brief summary

Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])., Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD).

Detailed description

Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)., Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)., Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)., Mean change in frequency of moderate to severe HF from baseline over time., 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., Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12.

Interventions

DRUGBAY 3427080 60 mg capsules placebo

Sponsors

Bayer Consumer Care AG, Bayer AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])., Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD).

Secondary

MeasureTime frame
Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)., Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)., Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)., Mean change in frequency of moderate to severe HF from baseline over time., 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., Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12.

Countries

Austria, Belgium, Finland, France, Germany, Hungary, Ireland, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026