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

Sponsor
Kissei Pharmaceutical Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05440383
Collaborator
(none)
264
2
31

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
264 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III Confirmatory Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: KLH-2109

Oral administration

Drug: KLH-2109
Oral administration

Active Comparator: Leuprorelin

Subcutaneous administration

Drug: Leuprorelin
Subcutaneous administration

Outcome Measures

Primary Outcome Measures

  1. Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration [Up to 12 weeks]

    PBAC (pictorial blood loss assessment chart) score

Secondary Outcome Measures

  1. 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 24 weeks]

    PBAC (pictorial blood loss assessment chart) score

  2. Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration [Up to 24 weeks]

    PBAC (pictorial blood loss assessment chart) score

  3. Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration [Up to 24 weeks]

    PBAC (pictorial blood loss assessment chart) score

  4. Change from baseline in blood hemoglobin [Up to 24 weeks]

    Hemoglobin

  5. Change rate from baseline in myoma volume [Up to 24 weeks]

    Myoma volume

  6. Change rate from baseline in uterine volume [Up to 24 weeks]

    Uterine volume

  7. Change from baseline in UFS-QOL score [Up to 24 weeks]

    UFS-QOL (uterine fibroid symptom and QOL) score

  8. Incidence of adverse events and adverse drug reactions [Up to 24 weeks]

    Adverse events and adverse drug reactions

  9. Change rate from baseline in bone metabolic markers (BAP and serum NTx) [Up to 24 weeks]

    Bone metabolic markers (BAP and serum NTx)

  10. Change rate from baseline in bone density (DXA) [Up to 24 weeks]

    Bone density, T-score

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Kissei Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Yoshitaka Shimizu, Kissei Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05440383
Other Study ID Numbers:
  • KLH2301
First Posted:
Jun 30, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022