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

June 3, 2019 updated by: Kissei Pharmaceutical Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

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
      • Multiple Locations, 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?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KLH-2109, low dose
Drug: Placebo
Drug: KLH-2109
Experimental: KLH-2109, medium dose
Drug: Placebo
Drug: KLH-2109
Experimental: KLH-2109, high dose
Drug: KLH-2109
Experimental: KLH-2109, lowest dose
Drug: Placebo
Drug: KLH-2109
Placebo Comparator: Placebo
First 12 week period; Placebo, Second 12 week period; randomize to one of the KLH-2109 dose levels
Drug: Placebo
Other: Leuprorelin acetate
Active reference
Drug: Leuprorelin acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of average Numerical Rating Scale (NRS) score of pelvic pain
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidences of adverse events
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

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

Sponsor

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 Major Dates

Study Start (Actual)

May 9, 2016

Primary Completion (Actual)

March 23, 2018

Study Completion (Actual)

March 23, 2018

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLH1204

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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