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The purpose of this study is to evaluate the efficacy, safety, and dose-response relationship of KLH-2109 compared to placebo in Japanese patients with endometriosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KLH-2109, lowest dose | Experimental |
| |
| KLH-2109, low dose | Experimental |
| |
| KLH-2109, medium dose | Experimental |
| |
| KLH-2109, high dose | Experimental |
| |
| Placebo | Placebo Comparator | First 12 week period; Placebo, Second 12 week period; randomize to one of the KLH-2109 dose levels |
|
| Leuprorelin acetate | Other | Active reference |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLH-2109 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Change of average Numerical Rating Scale (NRS) score of pelvic pain | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of adverse events | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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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| Placebo |
| Drug |
|
| Leuprorelin acetate | Drug |
|
| D000091662 | Genital Diseases |
| 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 |