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NCT01395940 Clinical Trial

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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01395940
Other study ID # KLH1201
Secondary ID
Status Completed
Phase Phase 2
First received July 14, 2011
Last updated October 29, 2013

Study information
Verified date October 2013
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 20
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: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• KLH-2109

• KLH-2109

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 8 weeks No
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