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The goal of this clinical trial was to determine whether the investigational drug KLH-2109 is effective for treating excessive menstrual bleeding in patients with uterine fibroids. Uterine fibroids are benign tumors that grown in the uterus.
The primary objectives of this trial were to answer the following questions:
Investigators will compare KLH-2109 with a standard of care treatment (control) to determine which treatment is more effective.
Participants will be required to follow:
A Multi-center, Randomized, Double-blind, Active-controlled, Parallel, Phase 3
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KLH-2109+ Leurprorelin acetate Placebo | Experimental | KLH-2109: 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection |
|
| KLH-2109 Placebo + Leurprorelin acetate | Active Comparator | KLH-2109 Placebo: 24 weeks(PO, QD) Leurprorelin acetate : 1.88mg or 3.75mg, Once every 4 weeks, subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLH-2109+ Leurprorelin acetate Placebo | Drug | KLH-2109 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a total PBAC score < 10 | Proportion of subjects with a total PBAC score < 10 from Week 6 to the day before Week 12 after administration of the investigational product | Week 6 to the day before Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a total PBAC score < 10 | Proportion of subjects with a total PBAC score < 10 from Week 2 to the day before Week 6 after administration of the investigational product | Week 6 , Week12, Week 18, Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Uterine fibroid patients with menorrhagia
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deageun Song | Contact | 82-2-840-6792 | daegeun.song@jwhealthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Jeong Yeol Park | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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randomized, double-blind, active-controlled, parallel, phase III
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|
| KLH-2109 Placebo + Leurprorelin acetate | Drug | KLH-2109 Placebo: for 24 weeks(PO, QD) Leurprorelin acetate Placebo: 1.88mg or 3.75mg , Once every 4 weeks, subcutaneous injection |
|
|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |