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
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- JW Pharmaceutical
- Enrollment
- 254
- Locations
- 1
- Primary Endpoint
- Proportion of subjects with a total PBAC score < 10
Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals diagnosed with uterine fibroids
Exclusion Criteria
- •Metrorrhagia or anovulatory bleeding
- •Patients with a history of total hysterectomy or bilateral oophorectomy
Arms & Interventions
KLH-2109+ Leurprorelin acetate Placebo
KLH-2109: 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection
Intervention: KLH-2109+ Leurprorelin acetate Placebo (Drug)
KLH-2109 Placebo + Leurprorelin acetate
KLH-2109 Placebo: 24 weeks(PO, QD) Leurprorelin acetate : 1.88mg or 3.75mg, Once every 4 weeks, subcutaneous injection
Intervention: KLH-2109 Placebo + Leurprorelin acetate (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Proportion of subjects with a total PBAC score < 10(Week 6 , Week12, Week 18, Week 24)