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

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: KLH-2109; Drug: placebo

• Registration Number: NCT01533532
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-12
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-15
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-29
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Female patients with endometriosis

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KLH-2109, low dose	KLH-2109	-
KLH-2109, medium dose	KLH-2109	-
KLH-2109, high dose	KLH-2109	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
The severity score of the pelvic pain	12 weeks

Trial Locations

Locations (1)

Japan; 🇯🇵 Tokyo and Other Japanese City, Japan