Bay98-7196, Dose Finding / POC Study

What Was Tested

This registered phase 2 trial tested Leuprolide for endometriosis.

It had six arms (groups): Placebo (placebo comparator), Levonorgestrel (experimental), one (experimental), one (experimental) and one (experimental).

Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection.

The registry classes the interventions as drug.

Who Took Part

The registry lists 319 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: Premenopausal women18 years and above at the time of screening. Moderate to severe endometriosis-associated pelvic pain (EAPP) of ≥5 in the last 28 days before screening visit 1 measured on the numeric rating scale (NRS; i.e. 4-week recall period). Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed according to investigator's instruction.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment); any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results; any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

As a double-blind Leuprolide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2014-10-16 with completion listed for 2016-10-24.

It ran at 117 sites in United States (25), Japan (16), Germany (15), Czechia (9), Spain (9) and Finland (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 319 people with endometriosis.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, Endometriosis research.