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

NCT02778919 — Phase 2, Completed, Kissei Pharmaceutical Co., Ltd.

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Registry	NCT02778919
Status	Completed
Phase	Phase 2
Study type	Interventional
Sponsor	Kissei Pharmaceutical Co., Ltd. (Industry)
Conditions	Endometriosis
Interventions	KLH-2109, Placebo, Leuprorelin acetate (Drug)
Dates	start 2016-05-09, primary completion 2018-03-23, completion 2018-03-23, first posted 2016-05-20, last updated 2019-06-04
Locations	1 site in Japan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
KLH-2109, lowest dose	Experimental	Drug: KLH-2109; Drug: Placebo
KLH-2109, low dose	Experimental	Drug: KLH-2109; Drug: Placebo
KLH-2109, medium dose	Experimental	Drug: KLH-2109; Drug: Placebo
KLH-2109, high dose	Experimental	Drug: KLH-2109
Placebo	Placebo comparator	Drug: Placebo	First 12 week period; Placebo, Second 12 week period; randomize to one of the KLH-2109 dose levels
Leuprorelin acetate	Other	Drug: Leuprorelin acetate	Active reference

KLH-2109 (Drug)
Placebo (Drug)
Leuprorelin acetate (Drug)

+Outcome measures

Primary outcomes

Change of average Numerical Rating Scale (NRS) score of pelvic pain [12 weeks]

Secondary outcomes

Incidences of adverse events [24 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
	Multiple Locations	Japan