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

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: KLH-2109; Drug: Leuprorelin acetate; Drug: Placebo

• Registration Number: NCT02778919
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-05-09
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-20
• Primary Completion: 2018-03-23
• Study Completion: 2018-03-23
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Female patients with endometriosis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KLH-2109, lowest dose	Placebo	-
KLH-2109, low dose	KLH-2109	-
KLH-2109, low dose	Placebo	-
KLH-2109, medium dose	KLH-2109	-
KLH-2109, medium dose	Placebo	-
KLH-2109, high dose	KLH-2109	-
Placebo	Placebo	First 12 week period; Placebo, Second 12 week period; randomize to one of the KLH-2109 dose levels
KLH-2109, lowest dose	KLH-2109	-
Leuprorelin acetate	Leuprorelin acetate	Active reference

Primary Outcome Measures

Name	Time	Method
Change of average Numerical Rating Scale (NRS) score of pelvic pain	12 weeks

Secondary Outcome Measures

Name	Time	Method
Incidences of adverse events	24 weeks