MedTrace Logo

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

NCT04614246 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2023-08-01

Study results available
· View outcomes & findings →

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

DRUG

BAY1817080

Tablet, oral administration

DRUG

Elagolix

Tablet, oral administration

DRUG

Placebo

Tablet, oral administration

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-29
Primary Completion
2022-01-17
Completion
2022-05-03
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Norway
  • Poland
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614246 on ClinicalTrials.gov