NCT04454424 is a Phase 1 clinical trial of BAY1817080 in Endometriosis Related Pain, sponsored by Bayer.

Who is sponsoring NCT04454424?

NCT04454424 is sponsored by Bayer.

What drugs are being tested in NCT04454424?

Interventions in NCT04454424: BAY1817080, Midazolam.

What condition does NCT04454424 study?

NCT04454424 studies Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough.

Is NCT04454424 still recruiting?

NCT04454424 is currently completed. Last updated 20 January 2023.

Last reviewed 2023-01-20 · How we verify

NCT04454424

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study on the Safety of BAY1817080, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug in Participants With Impaired Liver Function or Normal Liver Function

Completed Phase 1 Last updated 20 January 2023

What this trial tests

Phase 1 trial testing BAY1817080 in Endometriosis Related Pain in 37 participants. Completed in 15 December 2021.

Timeline

23 July 2020

Primary endpoint
24 June 2021

15 December 2021

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	37
Start date	23 July 2020
Primary completion	24 June 2021
Estimated completion	15 December 2021
Sites	2 locations across United States

Drugs / interventions tested

BAY1817080 — full drug profile →
Midazolam (midazolam) — full drug profile →

Conditions studied

Endometriosis Related Pain — all drugs for Endometriosis Related Pain →
Overactive Bladder — all drugs for Overactive Bladder →
Diabetic Neuropathic Pain — all drugs for Diabetic Neuropathic Pain →
Refractory or Unexplained Chronic Cough — all drugs for Refractory or Unexplained Chronic Cough →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 79, any sex, with Endometriosis Related Pain or Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the bladder is unable to hold urine normally (overactive bladder, OAB) or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis). In this study researchers want to learn more about the safety of BAY1817080, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as tablet in participants with mild, moderate or severe hepatic impairment and participants with normal liver function matched for age-, gender-, weight and race. The study will enroll 36 male and female participants in the age between 18 and 79 years. Participants with mild or moderate hepatic impairment and the matching participants will take multiple oral doses of study drug depending on the study plan. Participants with severe hepatic impairment and the matching participants will take a single oral dose of study drug during the study. Data from this study will provide researcher important information for further development of the study drug in particular on dose recommendation for patients with hepatic impairment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

A Lifelong Impact on Endometriosis: Pathophysiology and Pharmacological Treatment.
Chen LH, Lo WC, Huang HY, Wu HM. · · 2023 · cited 43× · PMID 37108664 · DOI 10.3390/ijms24087503
Safety and efficacy of gefapixant, a novel drug for the treatment of chronic cough: A systematic review and meta-analysis of randomized controlled trials.
Abu-Zaid A, Aljaili AK, Althaqib A, Adem F, et al · · 2021 · cited 12× · PMID 34012479 · DOI 10.4103/atm.atm_417_20

Verify or expand the search:

Other trials of BAY1817080

Trials testing the same drug.

NCT04802343 — A Trial to Learn How BAY1817080 Moves Into, Through and Out of the Body and How Safe it is in Healthy Chinese Men · Phase 1 · completed
NCT04614246 — Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Compari · Phase 2 · terminated
NCT04641273 — A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants Wit · Phase 2 · terminated
NCT04562155 — Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patient · Phase 2 · completed
NCT04545580 — Clinical Study to Evaluate the Treatment Effect and Safety of BAY1817080 in Patients With Overactive Bladder (OAB) · Phase 2 · completed

Other recruiting trials for Endometriosis Related Pain

Currently open trials in the same condition.

NCT06795243 — Efficacy of Physical Therapy Treatment in Endometriosis and Its Relationship to Adherence Rates. · NA · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04454424 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 20 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04454424.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing