NCT07378098 to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia
| NCT ID | NCT07378098 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | JW Pharmaceutical |
| Condition | Menorrhagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 254 participants |
| Start Date | 2026-02-03 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 254 participants in total. It began in 2026-02-03 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial was to determine whether the investigational drug KLH-2109 is effective for treating excessive menstrual bleeding in patients with uterine fibroids. Uterine fibroids are benign tumors that grown in the uterus. The primary objectives of this trial were to answer the following questions: * Does KLH-2109 lower the amount of menstrual bleeding? * Does KLH-2109 reduce menstrual bleeding? * Is KLH-2109 safe for participants to use? Investigators will compare KLH-2109 with a standard of care treatment (control) to determine which treatment is more effective. Participants will be required to follow: * Take either KLH-2109 or the common treatment as a pill * Visit the clinic regularly for health checkups and safety tests * Keep track of their bleeding and any health changes during the study
Eligibility Criteria
Inclusion Criteria: * Individuals diagnosed with uterine fibroids Exclusion Criteria: * Metrorrhagia or anovulatory bleeding * Patients with a history of total hysterectomy or bilateral oophorectomy
Contact & Investigator
Jeong Yeol Park
PRINCIPAL INVESTIGATOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT07378098 clinical trial?
This trial is open to female participants only, aged 19 Years or older, studying Menorrhagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07378098 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 254 participants.
Is NCT07378098 currently recruiting?
Yes, NCT07378098 is actively recruiting participants. Contact the research team at daegeun.song@jwhealthcare.com for enrollment information.
Where is the NCT07378098 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07378098 clinical trial?
NCT07378098 is sponsored by JW Pharmaceutical. The principal investigator is Jeong Yeol Park at Asan Medical Center. The trial plans to enroll 254 participants.