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NCT02778919 Clinical Trial

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

Endometriosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02778919
Other study ID # KLH1204
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 9, 2016
Est. completion date March 23, 2018

Study information
Verified date June 2019
Source Kissei Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date March 23, 2018
Est. primary completion date March 23, 2018
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

Related Conditions & MeSH terms

Intervention

Drug:
• KLH-2109

• Placebo

• Leuprorelin acetate

Locations
Country Name City State
n/a

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 Change of average Numerical Rating Scale (NRS) score of pelvic pain 12 weeks
Secondary Incidences of adverse events 24 weeks
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