A Randomized, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2)
- Registration Number
- NCT01533532
- 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
- 100
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 KLH-2109, low dose KLH-2109 - KLH-2109, medium dose KLH-2109 - KLH-2109, high dose KLH-2109 - placebo placebo -
- Primary Outcome Measures
Name Time Method The severity score of the pelvic pain 12 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 does KLH-2109 target in endometriosis pathophysiology and how does it compare to GnRH antagonists?
How does KLH-2109's efficacy in phase II trials compare to standard-of-care hormonal therapies for endometriosis?
Which biomarkers correlate with KLH-2109 treatment response in endometriosis patients based on phase II data?
What adverse events were observed in Kissei Pharmaceutical's NCT01533532 trial and how do they align with GnRH inhibitor profiles?
Are there combination therapies or competitor drugs in development alongside KLH-2109 for endometriosis treatment?
Trial Locations
- Locations (1)
Japan
🇯🇵Tokyo and Other Japanese City, Japan
Japan🇯🇵Tokyo and Other Japanese City, Japan