Ireland
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Active, not recruiting Phase 3

A Clinical Study of KLH-2109 in Patients With Endometriosis

NCT07015268 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2025-06-09
Last updated
2026-03-02

Condition(s) studied

Endometriosis

Investigational drug(s) / intervention(s)

KLH-2109Leuprorelin acetate →

KLH-2109: \- KLH-2109 tablet: Oral administration \- Leuprorelin acetate placebo: Subcutaneous administration

Leuprorelin acetate: \- KLH-2109 placebo tablet: Oral administration \- Leuprorelin acetate: Subcutaneous administration

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Change from baseline in the maximum NRS score for pelvic pain during 28 days prior to 12 weeks of the investigational product treatment — 12 weeks
    NRS score for pelvic pain: The NRS score for pelvic pain is an integer scale of 0 to 10 in which the worst daily pain associated with endometriosis is scored as 0 for "no pain" and 10 for "the worst pain imaginable."

Trial sites (1)

FacilityCityRegionStatus
Research Site Multiple Locations Japan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07015268 on ClinicalTrials.gov ↗ ← All trials in Japan