A Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis
- Registration Number
- NCT01629420
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
- Female patients with endometriosis
Exclusion Criteria
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug:KLH-2109 lower dose KLH-2109 - Drug:KLH-2109 higher dose KLH-2109 -
- Primary Outcome Measures
Name Time Method The severity score of the pelvic pain 8 weeks
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie KLH-2109's efficacy in endometriosis treatment?
How does KLH-2109 compare to GnRH agonists in managing endometriosis symptoms and recurrence rates?
Which biomarkers correlate with KLH-2109 response in estrogen-dependent endometriosis subtypes?
What adverse events are associated with KLH-2109 in Phase II endometriosis trials and how are they managed?
Are there synergistic combination therapies involving KLH-2109 for endometriosis, such as aromatase inhibitors or anti-inflammatory agents?
Trial Locations
- Locations (1)
Japan
🇯🇵Tokyo and Other Japanese City, Japan