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A Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis

NCT ID: NCT01629420

Last Updated: 2014-05-30

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

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Endometriosis

Keywords

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Gonadotropin-Releasing Hormone (GnRH) antagonist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug:KLH-2109 lower dose

Group Type EXPERIMENTAL

KLH-2109

Intervention Type DRUG

Drug:KLH-2109 higher dose

Group Type EXPERIMENTAL

KLH-2109

Intervention Type DRUG

Interventions

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KLH-2109

Intervention Type DRUG

KLH-2109

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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Japan

Tokyo and Other Japanese City, , Japan

Site Status

Countries

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Japan

Other Identifiers

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KLH1203

Identifier Type: -

Identifier Source: org_study_id