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

• Sponsor: Kissei Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01533532
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: KLH-2109; Drug: KLH-2109; Drug: KLH-2109; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Placebo-controlled, Double-blind Phase II Study of KLH-2109 in Patients With Endometriosis(2)

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KLH-2109, low dose	Drug: KLH-2109
Experimental: KLH-2109, medium dose	Drug: KLH-2109
Experimental: KLH-2109, high dose	Drug: KLH-2109
Placebo Comparator: placebo	Drug: placebo

Outcome Measures

Primary Outcome Measures

1. The severity score of the pelvic pain [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female patients with endometriosis

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Japan	Tokyo and Other Japanese City		Japan

Sponsors and Collaborators

• Kissei Pharmaceutical Co., Ltd.

Investigators

• Study Director: Tatsuro Takei, Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kissei Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01533532
• Other Study ID Numbers: KLH1202
• First Posted: Feb 15, 2012
• Last Update Posted: May 30, 2014
• Last Verified: May 1, 2014

• Keywords provided by Kissei Pharmaceutical Co., Ltd.: Gonadotropin-Releasing Hormone (GnRH) antagonist
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of May 30, 2014