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A Randomized, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01533532
First Posted: February 15, 2012
Last Update Posted: May 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
February 12, 2012
February 15, 2012
May 30, 2014
Not Provided
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The severity score of the pelvic pain [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT01533532 on ClinicalTrials.gov Archive Site
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A Randomized, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2)
A Multicenter, Randomized, Placebo-controlled, Double-blind Phase II Study of KLH-2109 in Patients With Endometriosis(2)
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Endometriosis
  • Drug: KLH-2109
  • Drug: placebo
  • Experimental: KLH-2109, low dose
    Intervention: Drug: KLH-2109
  • Experimental: KLH-2109, medium dose
    Intervention: Drug: KLH-2109
  • Experimental: KLH-2109, high dose
    Intervention: Drug: KLH-2109
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
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Inclusion Criteria:

  • Female patients with endometriosis

Exclusion Criteria:

  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Sexes Eligible for Study: Female
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01533532
KLH1202
No
Not Provided
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Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
Not Provided
Study Director: Tatsuro Takei Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP