A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide.

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

Oral administration.

Subcutaneous administration.

The registry classes the interventions as drug.

Who Took Part

287 actual participants took part.

It was open to women only aged from 20 years with no upper age limit.

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

Examples of who could join: Premenopausal Japanese woman diagnosed with uterine fibroids. Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions:. Larger than a certain standard. Not receiving surgical treatment. Patients with a normal menstrual cycle.

The full record lists 7 inclusion and 3 exclusion criteria; among the exclusions: patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis; patients with undiagnosed abnormal genital bleeding.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Leuprolide group and the comparison group ran side by side rather than switching.

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, investigator and outcomes assessor.

It started in 2022-10-11 with completion listed for 2024-08-21.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration (time frame: Up to 12 weeks).

It also tracked 10 secondary outcomes, for example Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration, Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration, Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration, Change from baseline in blood hemoglobin, Change rate from baseline in myoma volume and Change rate from baseline in uterine volume.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 287 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.