A Clinical Study of KLH-2109 in Patients With Endometriosis

NCT ID: NCT07015268

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-11-30

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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

KLH-2109 group

Oral administration

Group Type: EXPERIMENTAL

KLH-2109

Intervention Type: DRUG

• KLH-2109 tablet: Oral administration

• Leuprorelin acetate placebo: Subcutaneous administration

Leuprorelin group

Subcutaneous administration

Group Type: ACTIVE_COMPARATOR

Leuprorelin acetate

Intervention Type: DRUG

• KLH-2109 placebo tablet: Oral administration

• Leuprorelin acetate: Subcutaneous administration

Interventions

KLH-2109

• KLH-2109 tablet: Oral administration

• Leuprorelin acetate placebo: Subcutaneous administration

Intervention Type: DRUG

Leuprorelin acetate

• KLH-2109 placebo tablet: Oral administration

• Leuprorelin acetate: Subcutaneous administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoshitaka Shimizu

Role: STUDY_DIRECTOR

Kissei Pharmaceutical Co., Ltd.

Locations

Research Site

Multiple Locations, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Yoshitaka Shimizu

Role: CONTACT

rinsyousiken@pharm.kissei.co.jp

Email only

Other Identifiers

Under registration

Identifier Type: OTHER

Identifier Source: secondary_id

KLH1301

Identifier Type: -

Identifier Source: org_study_id