MenorrhagiaPhase 3NCT07378098
to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia
A Phase 3 study of Menorrhagia and Uterine Fibroids, run by JW Pharmaceutical at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Menorrhagia, Uterine Fibroids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Feb 2026to 3 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with uterine fibroids
Who cannot join
- Metrorrhagia or anovulatory bleeding
- Patients with a history of total hysterectomy or bilateral oophorectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Jeong Yeol Park, 02-3010-3629
About this study
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
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:
Read more
- 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
Read the detailed description
A Multi-center, Randomized, Double-blind, Active-controlled, Parallel, Phase 3
- Conditions
- Menorrhagia, Uterine Fibroids
- Being tested
- KLH-2109+ Leurprorelin acetate Placebo, KLH-2109 Placebo + Leurprorelin acetate
- Keywords
- Uterine Fibroids, Menorrhagia
- Medical subject headings
- Menorrhagia, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLH-2109+ Leurprorelin acetate PlaceboDrug
Also called KLH-2019+ Leurprorelin acetate Placebo
KLH-2109 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection
KLH-2109 Placebo + Leurprorelin acetateDrug
Also called KLH-2019 Placebo + Leurprorelin acetate Placebo
KLH-2109 Placebo: for 24 weeks(PO, QD) Leurprorelin acetate Placebo: 1.88mg or 3.75mg , Once every 4 weeks, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| KLH-2109+ Leurprorelin acetate Placebo | Experimental | KLH-2109: 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection Receives: Drug: KLH-2109+ Leurprorelin acetate Placebo |
| KLH-2109 Placebo + Leurprorelin acetate | Active comparator | KLH-2109 Placebo: 24 weeks(PO, QD) Leurprorelin acetate : 1.88mg or 3.75mg, Once every 4 weeks, subcutaneous injection Receives: Drug: KLH-2109 Placebo + Leurprorelin acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a total PBAC score < 10
Proportion of subjects with a total PBAC score < 10 from Week 6 to the day before Week 12 after administration of the investigational product
Measured: Week 6 to the day before Week 12
Secondary outcomes (1)
Proportion of subjects with a total PBAC score < 10
Proportion of subjects with a total PBAC score < 10 from Week 2 to the day before Week 6 after administration of the investigational product
Measured: Week 6 , Week12, Week 18, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start3 Feb 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion3 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, active-controlled, parallel, phase III
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeong Yeol Park, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378098
- Sponsor's protocol ID
- JW25301
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07378098
- Acronym / sponsor ID
- JW25301
- Conditions
- Menorrhagia, Uterine Fibroids
- Keywords
- Uterine Fibroids, Menorrhagia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 3 Sep 2028 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
A Multi-center, Randomized, Double-blind, Active-controlled, Parallel, Phase 3
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind, active-controlled, parallel, phase III
| Arm | Type | Receives |
|---|---|---|
| KLH-2109+ Leurprorelin acetate Placebo | Experimental | Drug: KLH-2109+ Leurprorelin acetate PlaceboKLH-2109: 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection |
| KLH-2109 Placebo + Leurprorelin acetate | Active comparator | Drug: KLH-2109 Placebo + Leurprorelin acetateKLH-2109 Placebo: 24 weeks(PO, QD) Leurprorelin acetate : 1.88mg or 3.75mg, Once every 4 weeks, subcutaneous injection |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals diagnosed with uterine fibroids
Key exclusion criteria (2 listed)
- Metrorrhagia or anovulatory bleeding
- Patients with a history of total hysterectomy or bilateral oophorectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KLH-2109+ Leurprorelin acetate PlaceboAlso: KLH-2019+ Leurprorelin acetate PlaceboKLH-2109 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection | Drug | KLH-2109+ Leurprorelin acetate Placebo |
| KLH-2109 Placebo + Leurprorelin acetateAlso: KLH-2019 Placebo + Leurprorelin acetate PlaceboKLH-2109 Placebo: for 24 weeks(PO, QD) Leurprorelin acetate Placebo: 1.88mg or 3.75mg , Once every 4 weeks, subcutaneous injection | Drug | KLH-2109 Placebo + Leurprorelin acetate |
Primary outcome
Proportion of subjects with a total PBAC score < 10
Time frame: Week 6 to the day before Week 12
Proportion of subjects with a total PBAC score < 10 from Week 6 to the day before Week 12 after administration of the investigational product
1 secondary outcome
Proportion of subjects with a total PBAC score < 10
Time frame: Week 6 , Week12, Week 18, Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeong Yeol Park principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Menorrhagia and Uterine Fibroids, run by JW Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deageun Song (82-2-840-6792, daegeun.song@jwhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with a total PBAC score < 10 (time frame: Week 6 to the day before Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.