A Clinical Study of KLH-2109 in Patients With Endometriosis

What Was Tested

This registered phase 3 trial tested Leuprolide for endometriosis.

It had two arms (groups): KLH-2109 group (experimental) and Leuprorelin group (active comparator).

Oral administration.

Subcutaneous administration.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 288 planned participants were the target.

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: A diagnosis of endometriosis by laparotomy or laparoscopy within 5 years before the start of the screening period;.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: patients with undiagnosed abnormal genital bleeding; patients with abnormal uterine bleeding or anovulatory bleeding judged to be severe by the principal investigator or subinvestigator; patients with concomitant chronic abdominal pain not attributable to endometriosis (such as irritable bowel syndrome \[ibs\] and interstitial cystitis).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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.

Blinding on both sides kept the endometriosis participants and researchers unaware of who received Leuprolide.

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

It started in 2025-06-09 with completion listed for 2027-11.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from baseline in the maximum NRS score for pelvic pain during 28 days prior to 12 weeks of the investigational product treatment (time frame: 12 weeks).

It also tracked 9 secondary outcomes, for example Change from baseline in and actual values of the maximum NRS score for pelvic pain every 28 days, Change from baseline in and actual values of the maximum severity score for pelvic pain every 28 days, Change from baseline in and actual values of severity score for temporary pain at each evaluation time point, Change from baseline in and actual values of severity score of objective findings at each evaluation time point, Percent change from baseline in and actual values of ovarian chocolate cyst volume at each evaluation time point and Change from baseline in and actual values of EHP-30 domain score at each evaluation time point.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 288 people with endometriosis.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, Endometriosis research.