to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KLH-2109+ Leurprorelin acetate Placebo, KLH-2109 Placebo + Leurprorelin acetate.
- Who it may be relevant to
- Registry conditions: Menorrhagia, Uterine Fibroids. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Drug KLH-2109+ Leurprorelin acetate Placebo
KLH-2109 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection - Drug KLH-2109 Placebo + Leurprorelin acetate
KLH-2109 Placebo: for 24 weeks(PO, QD) Leurprorelin acetate Placebo: 1.88mg or 3.75mg , Once every 4 weeks, subcutaneous injection
Primary outcome measures
- Proportion of subjects with a total PBAC score < 10 [Time frame: Week 6 to the day before Week 12]
Secondary outcome measures (1)
- Proportion of subjects with a total PBAC score < 10 [Time frame: Week 6 , Week12, Week 18, Week 24]
Eligibility criteria
Inclusion criteria
- Individuals diagnosed with uterine fibroids
Exclusion criteria
- Metrorrhagia or anovulatory bleeding
- Patients with a history of total hysterectomy or bilateral oophorectomy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Asan Medical Center — Seoul
Identifiers
NCT: NCT07378098 · JW25301