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Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KLH-2109 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLH-2109 | Drug | Oral administration |
| |
| Placebo |
| 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 |
| Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration | NRS (numeric rating scale) for pain | 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 12 weeks |
| Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end 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 Research Site | Multiple Locations | Japan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2022 | Oct 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2024 | Oct 3, 2025 | SAP_001.pdf |
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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 |
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| Drug |
Oral administration |
|
PBAC (pictorial blood loss assessment chart) score |
| Up to 12 weeks |
| Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days | NRS (numerical rating scale) | Up to 12 weeks |
| Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration | NRS (numerical rating scale) | Up to 12 weeks |
| Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days | NRS (numerical rating scale) | Up to 12 weeks |
| Average NRS score every 28 days for pain symptoms | NRS (numerical rating scale) | Up to 12 weeks |
| Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) during 28 days before end of study drug administration | NRS (numerical rating scale) | Up to 12 weeks |
| Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days | NRS (numerical rating scale) | Up to 12 weeks |
| Incidence of adverse events and adverse drug reactions | Adverse events and adverse drug reactions | Up to 12 weeks |