KLH-2109 for heavy menstrual bleeding from uterine fibroids
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
We are testing whether KLH-2109 can reduce heavy menstrual bleeding in people with uterine fibroids.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 254 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | JW Pharmaceutical Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07378098 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.