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

May 29, 2014 updated by: Kissei Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo and Other Japanese City, Japan
        • Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients with endometriosis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
Experimental: KLH-2109, low dose
Drug: KLH-2109
Experimental: KLH-2109, medium dose
Drug: KLH-2109
Experimental: KLH-2109, high dose
Drug: KLH-2109

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The severity score of the pelvic pain
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kissei Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Tatsuro Takei, Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 12, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

May 30, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLH1202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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