Clinical trial · Interventional
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
NCT05440383CI-TRIAL-00087206completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids (MeSH Heading: Leiomyoma) | Uterine Corpus Leiomyoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KLH-2109 | Drug | — | UNRESOLVED |
| Leuprorelin | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KLH-2109
- description
- Oral administration
- interventionNames
- Drug: KLH-2109
- type
- ACTIVE_COMPARATOR
- label
- Leuprorelin
- description
- Subcutaneous administration
- interventionNames
- Drug: Leuprorelin
Primary outcomes (1)
- measure
- Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration
- timeFrame
- Up to 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal Japanese woman diagnosed with uterine fibroids * Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions: * Larger than a certain standard * No calcification * Not receiving surgical treatment * Patients with a normal menstrual cycle * Patients diagnosed with menorrhagia Exclusion Criteria: * Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia) * Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis * Patients with undiagnosed abnormal genital bleeding
References
Publications (1)
- DERIVEDOsuga Y, Harada T, Takahashi H, Kawai A, Shimamura F; KLH2301 Investigators. Linzagolix versus leuprorelin in Japanese women with uterine leiomyomas: a phase 3, randomized, active-controlled, non-inferiority trial. Hum Reprod. 2026 Jul 6:deag106. doi: 10.1093/humrep/deag106. Online ahead of print. PMID 42406777