NCT04614246

Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb

A Randomized, Double-blind, Open for Active Comparator, Parallel-group, Multicenter Phase 2b Study to Assess the Efficacy and Safety of Three Different Doses of P2X3 Antagonist (BAY1817080) Versus Placebo and Elagolix 150 mg in Women With Symptomatic Endometriosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess safety and efficacy of BAY 1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include: * Study duration: 155 up to 285 days * Treatment duration: 84 days * Visit frequency: 3 laboratory every 2 weeks for participants on BAY 1817080 or placebo

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	BAY1817080	Tablet, oral administration
DRUG	Elagolix	Tablet, oral administration
DRUG	Placebo	Tablet, oral administration

Timeline

• Start date: 2021-01-29
• Primary completion: 2022-01-17
• Completion: 2022-05-03
• First posted: 2020-11-03
• Last updated: 2023-08-01
• Results posted: 2023-05-31

Locations

147 sites across 20 countries: United States, Austria, Belgium, Bulgaria, Canada, China, Czechia, Estonia, Finland, Germany, Greece, Hungary, Italy, Japan, Latvia, Lithuania, Norway, Poland, Slovakia, Spain

Regulatory

• FDA-regulated drug study