New pill could tame fibroid symptoms without surgery
NCT ID NCT05445167
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested an oral drug called KLH-2109 in 89 premenopausal Japanese women with uterine fibroids who had heavy bleeding and pain. The goal was to see if the drug could reduce bleeding and pain better than a placebo. The trial was completed and may point to a new way to manage fibroid symptoms without surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KLH-2109 (oral drug)
- What this could lead to
- If it works, this could offer a new non-surgical option to reduce heavy bleeding and pain from uterine fibroids.
- What could go wrong
- This is a small, completed Phase 3 trial in Japanese women only, so results may not apply to other groups. The drug may not work better than placebo, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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89 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Feb 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinical Research Site
Multiple Locations, Japan