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

Kissei

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: KLH-2109

Study type: Interventional

Funder types: Industry

Identifiers

NCT01395940

KLH1201

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients with endometriosis

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

KLH-2109, lower dose

Experimental group

Treatment:

Drug: KLH-2109

KLH-2109, higher dose

Experimental group

Treatment:

Drug: KLH-2109