A Clinical Study of KLH-2109 in Patients With Endometriosis

Launched by KISSEI PHARMACEUTICAL CO., LTD. · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called KLH-2109 for women who have endometriosis, a condition that can cause painful symptoms, especially pelvic pain. The trial aims to determine if KLH-2109 works just as well as an existing treatment called leuprorelin acetate. The goal is to see if KLH-2109 can effectively help manage pain related to endometriosis.

To participate in this trial, women must be at least 18 years old and premenopausal, meaning they are still having their menstrual cycles. They should have a confirmed diagnosis of endometriosis through specific medical examinations or tests, such as a surgery within the last five years or imaging studies showing signs of the disease. During the trial, participants will receive either KLH-2109 or leuprorelin acetate, but neither they nor the researchers will know which treatment they are getting to ensure fair results. It’s important for potential participants to be aware that certain health conditions, such as unexplained bleeding or other pelvic issues, may prevent them from joining the study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Premenopausal women aged 18 years or older (at the time of consent) with endometriosis who meet any of the following inclusion criteria.:
• • A diagnosis of endometriosis by laparotomy or laparoscopy within 5 years before the start of the screening period;
• • Ovarian chocolate cyst confirmed by MRI performed within 1 year before the start of the screening period or ultrasonography (transvaginal, transabdominal, or transrectal) carried out at the start of the screening period; or
• • Any of induration of the pouch of Douglas, limitation of uterine mobility, and pelvic tenderness based on the result of pelvic/rectal examination at the start of the screening period and a diagnosis of clinical endometriosis
• Exclusion Criteria:
• • 1. Patients with undiagnosed abnormal genital bleeding
• • 2. Patients with abnormal uterine bleeding or anovulatory bleeding judged to be severe by the principal investigator or subinvestigator
• • 3. Patients with concomitant chronic abdominal pain not attributable to endometriosis (such as irritable bowel syndrome \[IBS\] and interstitial cystitis)
• • 4. Patients with concomitant pelvic inflammatory disease or a history of pelvic inflammatory disease within 8 weeks before obtaining informed consent