Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 19 and up Women only

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.

More Uterine Fibroids trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages19 Years and up
SexWomen only
Enrollment254 (estimated)
SponsorJW Pharmaceutical
Industry-sponsored
Locations1 site (Seoul)
StatusRecruiting
StartedFebruary 3, 2026
Main results expectedMarch 31, 2028
Study endsSeptember 3, 2028
Registry record updatedMay 1, 2026
Trial IDNCT07378098 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.