Back to resultsA Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)
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
KLH-2109, lower dose
KLH-2109, higher dose
Arm Description
Outcomes
Primary Outcome Measures
The severity score of the pelvic pain
Secondary Outcome Measures
Full Information
NCT ID
NCT01395940
First Posted
July 14, 2011
Last Updated
October 29, 2013
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01395940
Brief Title
A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)
Official Title
A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(1)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
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 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KLH-2109, lower dose
Arm Type
Experimental
Arm Title
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsumi Hontani
Organizational Affiliation
Kissei Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Japan
City
Tokyo and Other Japanese City
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)
We'll reach out to this number within 24 hrs