Back to resultsA Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KLH-2109
KLH-2109
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Gonadotropin-Releasing Hormone (GnRH) antagonist
Eligibility Criteria
Inclusion Criteria:
- Female patients with endometriosis
Exclusion Criteria:
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Sites / Locations
- Japan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Drug:KLH-2109 lower dose
Drug:KLH-2109 higher dose
Arm Description
Outcomes
Primary Outcome Measures
The severity score of the pelvic pain
Secondary Outcome Measures
Full Information
NCT ID
NCT01629420
First Posted
June 25, 2012
Last Updated
May 29, 2014
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01629420
Brief Title
A Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis
Official Title
A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(3)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Gonadotropin-Releasing Hormone (GnRH) antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Arm Title
Drug:KLH-2109 lower dose
Arm Type
Experimental
Arm Title
Drug:KLH-2109 higher dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KLH-2109
Intervention Type
Drug
Intervention Name(s)
KLH-2109
Primary Outcome Measure Information:
Title
The severity score of the pelvic pain
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients with endometriosis
Exclusion Criteria:
Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Facility Information:
Facility Name
Japan
City
Tokyo and Other Japanese City
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis
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