A Clinical Study of KLH-2109 in Patients With Endometriosis

Kissei

Status and phase: Enrolling; Phase 3

Conditions: Endometriosis

Treatments: Drug: KLH-2109; Drug: Leuprorelin acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT07015268

KLH1301

Under registration (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 288 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

288 participants in 2 patient groups

KLH-2109 group

Experimental group

Description:

Oral administration

Treatment:

Drug: KLH-2109

Leuprorelin group

Active Comparator group

Description:

Subcutaneous administration

Treatment:

Drug: Leuprorelin acetate