A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia (NCT05440383) | Clinical Trial Compass
CompletedPhase 3
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
Japan287 participantsStarted 2022-10-11
Plain-language summary
Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia
Who can participate
Age range
20 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Premenopausal Japanese woman diagnosed with uterine fibroids
* 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
Exclusion Criteria:
* Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia)
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a PBAC score — a pictorial blood loss assessment — to measure whether periods became lighter after 6 to 12 weeks on KLH-2109; can you explain what that score means in practice and whether the results suggest a meaningful reduction in heavy bleeding for women like me?
2Since this was a Phase 3 trial and recruitment is now completed, has the results data been published or submitted anywhere, and does it change how you'd think about KLH-2109 as a potential option compared to treatments I could access today?
3The trial focused specifically on women with uterine fibroids who also had menorrhagia — heavy menstrual bleeding — so given my own situation, do you think my bleeding pattern and fibroid type are similar enough to what was studied that these results would be relevant to my care?
4Because the study only measured outcomes out to 12 weeks, do we know anything yet about whether the benefit continues beyond that timeframe, and is that a gap that would concern you for a longer-term treatment plan?
5Are there standard treatments for fibroid-related heavy bleeding — like hormonal therapies or surgical options — that I should consider first, before thinking about a newer drug like KLH-2109 that may not yet be widely available?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration