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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01533532
First received: February 12, 2012
Last updated: May 6, 2013
Last verified: May 2013

February 12, 2012
May 6, 2013
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The severity score of the pelvic pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.
 
Active, not recruiting
100
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Inclusion Criteria:

  • Female patients with endometriosis

Exclusion Criteria:

  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01533532
KLH1202
No
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 2013

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