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Trial record 2 of 9 for:    klh | First posted from 01/01/2011 to 02/01/2012
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A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)

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.
 
ClinicalTrials.gov Identifier: NCT01395940
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : October 30, 2013
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: KLH-2109 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(1)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: KLH-2109, lower dose Drug: KLH-2109
Experimental: KLH-2109, higher dose Drug: KLH-2109


Outcome Measures
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Primary Outcome Measures :
  1. The severity score of the pelvic pain [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients with endometriosis

Exclusion Criteria:

  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395940


Locations
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Japan
Japan
Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
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Study Director: Katsumi Hontani Kissei Pharmaceutical Co., Ltd.
More Information
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ClinicalTrials.gov Identifier: NCT01395940    
Other Study ID Numbers: KLH1201
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013
Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Gonadotropin-Releasing Hormone (GnRH) antagonist
Additional relevant MeSH terms:
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Endometriosis