Clinical trial NCT07015268: A Clinical Study of KLH-2109 in Patients With Endometriosis
Official title: Phase III Confirmatory Study of KLH-2109 in Patients With Endometriosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Endometriosis
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To verify the non-inferiority of KLH-2109 to leuprorelin acetate in a double-blind manner in terms of efficacy in endometriosis patients with pelvic pain.


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

Primary outcomes:
measure: Change from baseline in the maximum NRS score for pelvic pain during 28 days prior to 12 weeks of the investigational product treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in and actual values of the maximum NRS score for pelvic pain every 28 days
timeFrame: Up to 24 weeks
measure: Change from baseline in and actual values of the maximum severity score for pelvic pain every 28 days
timeFrame: Up to 24 weeks
measure: Change from baseline in and actual values of severity score for temporary pain at each evaluation time point
timeFrame: Up to 24 weeks
measure: Change from baseline in and actual values of severity score of objective findings at each evaluation time point
timeFrame: Up to 24 weeks
measure: Percent change from baseline in and actual values of ovarian chocolate cyst volume at each evaluation time point
timeFrame: Up to 24 weeks
measure: Change from baseline in and actual values of EHP-30 domain score at each evaluation time point
timeFrame: Up to 24 weeks
measure: Incidence of adverse events and treatment-related adverse events
timeFrame: Up to 24 weeks
measure: Percent change from baseline in bone mineral density at each evaluation time point
timeFrame: Up to 24 weeks
measure: Change from baseline in T-score at each evaluation time point
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Research Site
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Yoshitaka Shimizu
role: STUDY_DIRECTOR
References: