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

Primary Purpose

Endometriosis

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

KLH-2109

placebo

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Gonadotropin-Releasing Hormone (GnRH) antagonist

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

Japan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

KLH-2109, low dose

KLH-2109, medium dose

KLH-2109, high dose

placebo

Arm Description

Outcomes

Primary Outcome Measures

The severity score of the pelvic pain

Secondary Outcome Measures

Full Information

NCT ID

NCT01533532

First Posted

February 12, 2012

Last Updated

May 29, 2014

Sponsor

Kissei Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01533532

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

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

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

Double

Allocation

Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

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

Intervention Type

Drug

Intervention Name(s)

KLH-2109

Intervention Type

Drug

Intervention Name(s)

KLH-2109

Intervention Type

Drug

Intervention Name(s)

KLH-2109

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

The severity score of the pelvic pain

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Tatsuro Takei

Organizational Affiliation

Clinical Development Dept.,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, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2)

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