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Late Phase II Clinical Study of KLH-2109 in Patients With Endometriosis

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KLH-2109
Placebo
Leuprorelin acetate
Sponsored by
Kissei Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Endometriosis focused on measuring Endometriosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients with endometriosis

Exclusion Criteria:

  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Other

Arm Label

KLH-2109, lowest dose

KLH-2109, low dose

KLH-2109, medium dose

KLH-2109, high dose

Placebo

Leuprorelin acetate

Arm Description

First 12 week period; Placebo, Second 12 week period; randomize to one of the KLH-2109 dose levels

Active reference

Outcomes

Primary Outcome Measures

Change of average Numerical Rating Scale (NRS) score of pelvic pain

Secondary Outcome Measures

Incidences of adverse events

Full Information

First Posted
May 18, 2016
Last Updated
June 3, 2019
Sponsor
Kissei Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02778919
Brief Title
Late Phase II Clinical Study of KLH-2109 in Patients With Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 9, 2016 (Actual)
Primary Completion Date
March 23, 2018 (Actual)
Study Completion Date
March 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and dose-response relationship of KLH-2109 compared to placebo in Japanese patients with endometriosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis

7. Study Design

Study Phase
Phase 2

8. Arms, Groups, and Interventions

Arm Title
KLH-2109, lowest dose
Arm Type
Experimental
Arm Title
KLH-2109, low dose
Arm Type
Experimental
Arm Title
KLH-2109, medium dose
Arm Type
Experimental
Arm Title
KLH-2109, high dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
First 12 week period; Placebo, Second 12 week period; randomize to one of the KLH-2109 dose levels
Arm Title
Leuprorelin acetate
Arm Type
Other
Arm Description
Active reference
Intervention Type
Drug
Intervention Name(s)
KLH-2109
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Leuprorelin acetate
Primary Outcome Measure Information:
Title
Change of average Numerical Rating Scale (NRS) score of pelvic pain
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incidences of adverse events
Time Frame
24 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:
City
Multiple Locations
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Late Phase II Clinical Study of KLH-2109 in Patients With Endometriosis

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