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

Conditions

• Endometriosis

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BAY1817080 — DRUG
  Tablet, oral administration
• Elagolix — DRUG
  Tablet, oral administration
• Placebo — DRUG
  Tablet, oral administration

Study Details

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

Key Dates

Start date

Jan 29, 2021

Status verified

Jul 2023

Primary completion

Jan 17, 2022

Completion

May 3, 2022

Study Design

Enrollment

215 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BAY1817080 150 mg
  Participants will receive 150 mg of BAY1817080 twice daily over a 12-week intervention period
• Experimental: BAY1817080 75 mg
  Participants will receive 75 mg of BAY1817080 twice daily over a 12-week intervention period
• Experimental: BAY1817080 25 mg
  Participants will receive 25 mg of BAY1817080 twice daily over a 12-week intervention period
• Active Comparator: Elagolix
  Participants will receive 150 mg of Elagolix once daily over a 12-week intervention period
• Placebo Comparator: Placebo
  Participants will receive placebo matching BAY1817080 twice daily over a 12-week intervention period

Primary Outcome Measure

Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) [ Time Frame: change from baseline to week 12 ]

Locations (47)

Find similar trials in Birmingham, AL

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