A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain
NCT ID: NCT05445167
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
89 participants
INTERVENTIONAL
2022-10-11
2024-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KLH-2109
KLH-2109
Oral administration
Placebo
Placebo
Oral administration
Interventions
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KLH-2109
Oral administration
Placebo
Oral administration
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with pain symptoms associated with uterine fibroids
Exclusion Criteria
* 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
20 Years
FEMALE
No
Sponsors
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Kissei Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yoshitaka Shimizu
Role: STUDY_DIRECTOR
Kissei Pharmaceutical Co., Ltd.
Locations
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Clinical Research Site
Multiple Locations, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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KLH2302
Identifier Type: -
Identifier Source: org_study_id
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