to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia
Recruiting
Phase 3
Interventional Study
Menorrhagia
Uterine Fibroids
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 254 (estimated)
- Sponsor
- JW Pharmaceutical · Industry
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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 …
Trial Locations
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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
Contacts