Trials / Completed
CompletedNCT05440383
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
A Phase III Confirmatory Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 287 (actual)
- Sponsor
- Kissei Pharmaceutical Co., Ltd. · Industry
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KLH-2109 | Oral administration |
| DRUG | Leuprorelin | Subcutaneous administration |
Timeline
- Start date
- 2022-10-11
- Primary completion
- 2024-08-21
- Completion
- 2024-08-21
- First posted
- 2022-06-30
- Last updated
- 2025-03-14
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT05440383. Inclusion in this directory is not an endorsement.