Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Menorrhagia | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KLH-2109+ Leurprorelin acetate Placebo | Drug | — | UNRESOLVED |
| KLH-2109 Placebo + Leurprorelin acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KLH-2109+ Leurprorelin acetate Placebo
- description
- KLH-2109: 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection
- interventionNames
- Drug: KLH-2109+ Leurprorelin acetate Placebo
- type
- ACTIVE_COMPARATOR
- label
- KLH-2109 Placebo + Leurprorelin acetate
- description
- KLH-2109 Placebo: 24 weeks(PO, QD) Leurprorelin acetate : 1.88mg or 3.75mg, Once every 4 weeks, subcutaneous injection
- interventionNames
- Drug: KLH-2109 Placebo + Leurprorelin acetate
Primary outcomes (1)
- measure
- Proportion of subjects with a total PBAC score < 10
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals diagnosed with uterine fibroids Exclusion Criteria: * Metrorrhagia or anovulatory bleeding * Patients with a history of total hysterectomy or bilateral oophorectomy
References
Publications (0)
Data not yet available