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

NCT05445167 | Completed Phase 3

• 1 other identifier: KLH2302
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain

Conditions

Uterine Fibroids (MeSH Heading: Leiomyoma)

Outcome Measures

Primary Outcomes (2)

• 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

  Up to 12 weeks

• Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration

  NRS (numeric rating scale) for pain

  Up to 12 weeks

Secondary Outcomes (9)

• Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration

  Up to 12 weeks

• Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration

  Up to 12 weeks

• Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days

  Up to 12 weeks

• Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration

  Up to 12 weeks

• Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days

  Up to 12 weeks

Study Arms (2)

KLH-2109

EXPERIMENTAL

Drug: KLH-2109

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

KLH-2109 DRUG

Oral administration

KLH-2109

Placebo DRUG

Oral administration

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients with pain symptoms associated with uterine fibroids

You may not qualify if:

• 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

Sponsors & Collaborators

• Kissei Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Clinical Research Site

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

linzagolix

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Yoshitaka Shimizu

  Kissei Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 6, 2022
• Study Start: October 11, 2022
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-03

Locations

JP (1)