Uterine Fibroids (MeSH Heading: Leiomyoma)Phase 3NCT05440383

A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

A Phase 3 study testing KLH-2109 and Leuprorelin in people with Uterine Fibroids (MeSH Heading: Leiomyoma), run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia Read more about this study

Who is it for?: Ages 20 years and older, women only
Conditions the study is for: Uterine Fibroids (MeSH Heading: Leiomyoma)
What is being tested?: KLH-2109 and Leuprorelin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 287 participants
Where: 1 siteJapan
Study dates: 11 Oct 2022to 21 Aug 2024
Phase: Phase 3
Are there results?: None posted in the registry

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 20 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Premenopausal Japanese woman diagnosed with uterine fibroids
Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions:
Larger than a certain standard
No calcification
Not receiving surgical treatment
Patients with a normal menstrual cycle
Patients diagnosed with menorrhagia

Who cannot join

Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia)
Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis
Patients with undiagnosed abnormal genital bleeding

Trial locations and contacts

1 site in 1 country.

Japan1 site

Clinical Resarch Site
Multiple Locations

Other trials in Japan

About this study

Official title: A Phase III Confirmatory Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia

Conditions: Uterine Fibroids (MeSH Heading: Leiomyoma)
Being tested: KLH-2109, Leuprorelin
Medical subject headings: Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KLH-2109Drug
Oral administration
LeuprorelinDrug
Subcutaneous administration

Study groups in NCT05440383
Study group	Role	What they receive
KLH-2109	Experimental	Oral administration Receives: Drug: KLH-2109
Leuprorelin	Active comparator	Subcutaneous administration Receives: Drug: Leuprorelin

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 of less than 10 from Week 6 to 12 after beginning of study drug administration
PBAC (pictorial blood loss assessment chart) score
Measured: Up to 12 weeks

Secondary outcomes (10)

Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration
PBAC (pictorial blood loss assessment chart) score
Measured: Up to 24 weeks
Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration
PBAC (pictorial blood loss assessment chart) score
Measured: Up to 24 weeks
Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration
PBAC (pictorial blood loss assessment chart) score
Measured: Up to 24 weeks
Change from baseline in blood hemoglobin
Hemoglobin
Measured: Up to 24 weeks
Change rate from baseline in myoma volume
Myoma volume
Measured: Up to 24 weeks
Change rate from baseline in uterine volume
Uterine volume
Measured: Up to 24 weeks
Change from baseline in UFS-QOL score
UFS-QOL (uterine fibroid symptom and QOL) score
Measured: Up to 24 weeks
Incidence of adverse events and adverse drug reactions
Adverse events and adverse drug reactions
Measured: Up to 24 weeks
Change rate from baseline in bone metabolic markers (BAP and serum NTx)
Bone metabolic markers (BAP and serum NTx)
Measured: Up to 24 weeks
Change rate from baseline in bone density (DXA)
Bone density, T-score
Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 202221 Aug 2024

First posted30 Jun 2022
Study start11 Oct 2022
Primary completion21 Aug 2024
Study completion21 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Uterine Fibroids (MeSH Heading: Leiomyoma)Studies 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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 287 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05440383
Sponsor's protocol ID: KLH2301
Status last verified: Mar 2025
First submitted: 27 Jun 2022
Last updated: 14 Mar 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Osuga Y, Harada T, Takahashi H, Kawai A, Shimamura F; KLH2301 Investigators. Linzagolix versus leuprorelin in Japanese women with uterine leiomyomas: a phase 3, randomized, active-controlled, non-inferiority trial. Hum Reprod. 2026 Jul 6:deag106. doi: 10.1093/humrep/deag106. Online ahead of print.
PubMed 42406777

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Confirmatory Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
ClinicalTrials.gov ID: NCT05440383
Acronym / sponsor ID: KLH2301
Conditions: Uterine Fibroids (MeSH Heading: Leiomyoma)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 287 participants (actual)
Lead sponsor: Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 11 Oct 2022 (actual)
Primary completion: 21 Aug 2024 (actual)
Study completion: 21 Aug 2024 (actual)
First posted: 30 Jun 2022 (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.

Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
KLH-2109	Experimental	Drug: KLH-2109Oral administration
Leuprorelin	Active comparator	Drug: LeuprorelinSubcutaneous administration

Who may qualify

Ages: 20 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Premenopausal Japanese woman diagnosed with uterine fibroids
Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions:
Larger than a certain standard
No calcification
Not receiving surgical treatment

Key exclusion criteria (3 listed)

Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia)
Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis
Patients with undiagnosed abnormal genital bleeding

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-2109Oral administration	Drug	KLH-2109
LeuprorelinSubcutaneous administration	Drug	Leuprorelin

Primary outcome

Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration
Time frame: Up to 12 weeks
PBAC (pictorial blood loss assessment chart) score

10 secondary outcomes

Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration
Time frame: Up to 24 weeks
Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration
Time frame: Up to 24 weeks
Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration
Time frame: Up to 24 weeks
Change from baseline in blood hemoglobin
Time frame: Up to 24 weeks
Change rate from baseline in myoma volume
Time frame: Up to 24 weeks
Change rate from baseline in uterine volume
Time frame: Up to 24 weeks
Change from baseline in UFS-QOL score
Time frame: Up to 24 weeks
Incidence of adverse events and adverse drug reactions
Time frame: Up to 24 weeks
Change rate from baseline in bone metabolic markers (BAP and serum NTx)
Time frame: Up to 24 weeks
Change rate from baseline in bone density (DXA)
Time frame: Up to 24 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
Derived from this study: PubMed 42406777Osuga Y, Harada T, Takahashi H, Kawai A, Shimamura F; KLH2301 Investigators. Linzagolix versus leuprorelin in Japanese women with uterine leiomyomas: a phase 3, randomized, active-controlled, non-inferiority trial. Hum Reprod. 2026 Jul 6:deag106. doi: 10.1093/humrep/deag106. Online ahead of print.
Individual participant dataSharing planned: Undecided

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. This study is not recruiting at the moment.

Yoshitaka Shimizu study director

Kissei Pharmaceutical Co., Ltd.

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 testing KLH-2109 and Leuprorelin in people with Uterine Fibroids (MeSH Heading: Leiomyoma), run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.

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 7 inclusion and 3 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: finished, as of the sponsor's last update on 14 Mar 2025. 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 Japan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05440383, which also lists 1 linked publication.

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 14 Mar 2025.