to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia

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

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

A Multi-center, Randomized, Double-blind, Active-controlled, Parallel, Phase 3

Inclusion Criteria:

• Individuals diagnosed with uterine fibroids

Exclusion Criteria:

• Metrorrhagia or anovulatory bleeding
• Patients with a history of total hysterectomy or bilateral oophorectomy