to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age19+
SponsorJW Pharmaceutical
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals diagnosed with uterine fibroids
Disqualifiers
Metrorrhagia or anovulatory bleeding
Patients with a history of total hysterectomy or bilateral oophorectomy
Trial design
Design model
Parallel
Treatments tested in this trial
KLH-2109+ Leurprorelin acetate Placebo
DrugKLH-2109 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection
KLH-2109 Placebo + Leurprorelin acetate
DrugKLH-2109 Placebo: for 24 weeks(PO, QD) Leurprorelin acetate Placebo: 1.88mg or 3.75mg , Once every 4 weeks, subcutaneous injection
Treatment groups
254 Participants
are divided into 2 treatment groupsGroup A: KLH-2109+ Leurprorelin acetate PlaceboExperimental treatment 1 intervention
Group B: KLH-2109 Placebo + Leurprorelin acetateActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of subjects with a total PBAC score < 10
Proportion of subjects with a total PBAC score \< 10 from Week 6 to the day before Week 12 after administration of the investigational product
Time frame
Week 6 to the day before Week 12Secondary outcomes
1
Proportion of subjects with a total PBAC score < 10
Proportion of subjects with a total PBAC score \< 10 from Week 2 to the day before Week 6 after administration of the investigational product
Time frame
Week 6 , Week12, Week 18, Week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov