Trials / Active Not Recruiting
Active Not RecruitingNCT07015268
A Clinical Study of KLH-2109 in Patients With Endometriosis
Phase III Confirmatory Study of KLH-2109 in Patients With Endometriosis
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 288 (estimated)
- Sponsor
- Kissei Pharmaceutical Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KLH-2109 | \- KLH-2109 tablet: Oral administration \- Leuprorelin acetate placebo: Subcutaneous administration |
| DRUG | Leuprorelin acetate | \- KLH-2109 placebo tablet: Oral administration \- Leuprorelin acetate: Subcutaneous administration |
Timeline
- Start date
- 2025-06-09
- Primary completion
- 2027-11-01
- Completion
- 2027-11-01
- First posted
- 2025-06-11
- Last updated
- 2026-03-02
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT07015268. Inclusion in this directory is not an endorsement.