KLH-2109 for heavy menstrual bleeding from uterine fibroids
Official title: A Multi-center, Randomized, Double-blind, Active-controlled, Parallel, Phase 3 Study to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia
Run by JW Pharmaceutical · NCT07378098 · Data updated 2026-11-12
We are testing whether KLH-2109 can reduce heavy menstrual bleeding in people with uterine fibroids.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | Women only |
| Enrollment | 254 (estimated) |
| Sponsor | JW Pharmaceutical Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | February 3, 2026 |
| Main results expected | March 31, 2028 |
| Study ends | September 3, 2028 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07378098 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People diagnosed with uterine fibroids who experience heavy menstrual bleeding and meet the trial entry criteria (no metrorrhagia/anovulatory bleeding and no prior total hysterectomy or bilateral oophorectomy) are the ideal candidates.
✕Probably not a fit
Patients with metrorrhagia or anovulatory bleeding, or those who have had a total hysterectomy or bilateral oophorectomy, would not be expected to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 3, multicenter, randomized, double-blind, active-controlled, parallel-group trial comparing KLH-2109 with a standard treatment in people with uterine fibroids and menorrhagia. Participants will take either KLH-2109 or the comparator pill (with matching placebos) and attend regular clinic visits for safety checks and monitoring. Participants will track their menstrual bleeding and symptoms during the treatment period to measure changes in blood loss and report any side effects. Key inclusion criteria are a diagnosis of uterine fibroids with heavy menstrual bleeding, and key exclusions include metrorrhagia, anovulatory bleeding, prior total hysterectomy, or bilateral oophorectomy.
Why it matters
Potential benefit: If successful, KLH-2109 could reduce heavy menstrual bleeding and improve quality of life while providing a non-surgical treatment option.
How similar studies have gone: Hormone-suppressing drugs such as leuprorelin have reduced bleeding in prior studies, but KLH-2109 is a novel agent and is being tested in a late-stage trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals diagnosed with uterine fibroids Exclusion Criteria: * Metrorrhagia or anovulatory bleeding * Patients with a history of total hysterectomy or bilateral oophorectomy
Where it's running
-
Asan Medical Center
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Jeong Yeol Park — Asan Medical Center
- Study coordinator: Deageun Song
- Email: daegeun.song@jwhealthcare.com
- Phone: 82-2-840-6792
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.