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

What Was Tested

In this phase 2 trial, researchers set out to test Elagolix (non-peptide) for 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.

It had five arms (groups): one (experimental), one (experimental), one (experimental), Elagolix (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 215 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participant must be ≥ 18 years of age at the time of signing the informed consent. Both sub-criteria regarding pain symptoms must be fulfilled:. Willingness to use standardized rescue pain medications for EAPP (i.e. ibuprofen, acetaminophen and tramadol) and not use any prophylactic pain medication, according to investigator's instruction. Ability to swallow the study intervention, i.e., the different kinds of tablets, as complete units. Good general health (except for findings related to endometriosis) as proven by medical history, physical and gynecological examinations and laboratory test results.

The full record lists 12 inclusion and 28 exclusion criteria; among the exclusions: current pregnancy or less than 3 months since delivery, abortion or stop of lactation before visit 1a; hypersensitivity to any ingredient of the study intervention and/or the standardized rescue medications; known osteoporosis.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The endometriosis participants were allocated by chance, so the Elagolix (non-peptide) group and the comparison group should start out alike.

The Elagolix (non-peptide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the endometriosis participants and researchers unaware of who received Elagolix (non-peptide).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-01-29 with completion listed for 2022-01-17.

It ran at 147 sites in United States (47), Japan (20), Poland (11), Czechia (9), China (8) and Italy (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) (time frame: change from baseline to week 12).

It also tracked 2 secondary outcomes, for example Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set and Number of Participants With Treatment-emergent Adverse Events (TEAE).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Elagolix (non-peptide) in 215 people with endometriosis.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Elagolix (non-peptide) compound page, Endometriosis research.