BAY 3427080

DRUG3 trials

Sponsors

Bayer Consumer Care AG, Bayer AG

Conditions

Healthy volunteers (Vasomotor Symptoms as a sex hormone-dependent disorder in women and men)Sleep disturbances associated with menopauseVasomotor symptoms caused by adjuvant endocrine therapy in women withor at high risk for developing hormone-receptor positive breast cancer

Phase 1

(22081) Open-label, fixed sequence crossover study to determine the effects of a single dose of elinzanetant (BAY 3427080) on the pharmacokinetics of dabigatran etexilate in healthy participants

CompletedCTIS2022-500201-41-00

Bayer Consumer Care AG, Bayer AGHealthy volunteers (Vasomotor Symptoms as a sex hormone-dependent disorder in women and men)

Start: 2022-08-02End: 2022-11-14Target: 20Updated: 2022-10-19

Phase 2

(22423 NIRVANA) A randomized, parallel-group treatment, Phase 2, double-blind pilot study to investigate the efficacy and safety of elinzanetant compared with placebo for treatment of sleep disturbances associated with menopause

CompletedCTIS2023-504955-28-01

Bayer Consumer Care AG, Bayer AGSleep disturbances associated with menopause

Start: 2024-03-14End: 2024-07-31Target: 84Updated: 2024-12-04

Phase 3

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

Active, not recruitingCTIS2023-508265-33-00

Bayer Consumer Care AG, Bayer AGor at high risk for developing hormone-receptor positive breast cancer, Vasomotor symptoms caused by adjuvant endocrine therapy in women with

Start: 2022-10-13Target: 417Updated: 2026-01-20