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NCT01533532 Clinical Trial

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

Endometriosis Clinical Trial

Official title:
A Multicenter, Randomized, Placebo-controlled, Double-blind Phase II Study of KLH-2109 in Patients With Endometriosis(2)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01533532
Other study ID # KLH1202
Secondary ID
Status Completed
Phase Phase 2
First received February 12, 2012
Last updated May 29, 2014

Study information
Verified date May 2014
Source Kissei Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Female patients with endometriosis

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• KLH-2109

• KLH-2109

• KLH-2109

• placebo

Locations
Country Name City State
Japan Japan Tokyo and Other Japanese City

Sponsors (1)
Lead Sponsor Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The severity score of the pelvic pain 12 weeks No
See also
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