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

NCT ID: NCT02778919

Last Updated: 2019-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-09

Study Completion Date

2018-03-23

Brief Summary

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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.

Detailed Description

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Conditions

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Endometriosis

Study Groups

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KLH-2109, lowest dose

Group Type EXPERIMENTAL

KLH-2109

Intervention Type DRUG

Placebo

Intervention Type DRUG

KLH-2109, low dose

Group Type EXPERIMENTAL

KLH-2109

Intervention Type DRUG

Placebo

Intervention Type DRUG

KLH-2109, medium dose

Group Type EXPERIMENTAL

KLH-2109

Intervention Type DRUG

Placebo

Intervention Type DRUG

KLH-2109, high dose

Group Type EXPERIMENTAL

KLH-2109

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Leuprorelin acetate

Active reference

Group Type OTHER

Leuprorelin acetate

Intervention Type DRUG

Interventions

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KLH-2109

Intervention Type DRUG

Placebo

Intervention Type DRUG

Leuprorelin acetate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female patients with endometriosis

Exclusion Criteria

* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Multiple Locations, , Japan

Site Status

Countries

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Japan

Other Identifiers

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KLH1204

Identifier Type: -

Identifier Source: org_study_id

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