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Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KLH-2109 | Experimental | Oral administration |
|
| Leuprorelin | Active Comparator | Subcutaneous administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLH-2109 | Drug | Oral administration |
| |
| Leuprorelin |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration | PBAC (pictorial blood loss assessment chart) score | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration | PBAC (pictorial blood loss assessment chart) score | Up to 24 weeks |
| Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshitaka Shimizu | Kissei Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Resarch Site | Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42406777 | Derived | Osuga 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. |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000716911 | linzagolix |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
Subcutaneous administration |
|
PBAC (pictorial blood loss assessment chart) score |
| Up to 24 weeks |
| Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration | PBAC (pictorial blood loss assessment chart) score | Up to 24 weeks |
| Change from baseline in blood hemoglobin | Hemoglobin | Up to 24 weeks |
| Change rate from baseline in myoma volume | Myoma volume | Up to 24 weeks |
| Change rate from baseline in uterine volume | Uterine volume | Up to 24 weeks |
| Change from baseline in UFS-QOL score | UFS-QOL (uterine fibroid symptom and QOL) score | Up to 24 weeks |
| Incidence of adverse events and adverse drug reactions | Adverse events and adverse drug reactions | Up to 24 weeks |
| Change rate from baseline in bone metabolic markers (BAP and serum NTx) | Bone metabolic markers (BAP and serum NTx) | Up to 24 weeks |
| Change rate from baseline in bone density (DXA) | Bone density, T-score | Up to 24 weeks |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |