A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain (NCT05445167) | Clinical Trial Compass
CompletedPhase 3
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain
Japan89 participantsStarted 2022-10-11
Plain-language summary
Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain
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
* Patients with pain symptoms associated with uterine fibroids
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 tested KLH-2109 specifically for uterine fibroid-related heavy bleeding and pain — can you tell me whether the results showed meaningful reductions in both of those symptoms, and whether those results would be relevant to my specific situation?
2The trial measured bleeding control using a PBAC score below 10 by weeks 6 to 12 — in plain terms, what does that target mean in practice, and is that level of bleeding reduction something that would matter for my quality of life?
3Since this was a Phase 3 trial and recruitment is now completed, does that mean KLH-2109 is close to being approved, and should I be looking at this as a possible future option rather than something available to me right now?
4Compared to treatments I might already be eligible for — like hormonal therapies, a levonorgestrel IUD, or surgical options like myomectomy — how does what we know about KLH-2109 so far compare in terms of effectiveness and safety for someone with my profile?
5The trial tracked both heavy menstrual bleeding and pain separately — given that my main concern is one more than the other, does the evidence from this study suggest KLH-2109 addresses both well enough to be worth pursuing?
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
Timeframe: Up to 12 weeks
2
Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration