A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)

NCT01395940 — Phase 2, Completed, 20 participants, Kissei Pharmaceutical Co., Ltd.

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A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(1)

Registry	NCT01395940
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	Kissei Pharmaceutical Co., Ltd. (Industry)
Conditions	Endometriosis
Interventions	KLH-2109 (Drug)
Dates	first posted 2011-07-18, last updated 2013-10-30
Locations	1 site in Japan

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
KLH-2109, lower dose	Experimental	Drug: KLH-2109
KLH-2109, higher dose	Experimental	Drug: KLH-2109

KLH-2109 (Drug)
KLH-2109 (Drug)

+Outcome measures

Primary outcomes

The severity score of the pelvic pain [8 weeks]

+Eligibility

Sex: Female, ages: 20 Years to any

Inclusion Criteria:

* Female patients with endometriosis

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Japan	Tokyo and Other Japanese City	Japan

+Investigators

Katsumi Hontani, Study director, Kissei Pharmaceutical Co., Ltd.