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

Kissei

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: KLH-2109; Drug: Placebo; Drug: Leuprorelin acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02778919

KLH1204

Details and patient eligibility

About

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.

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

0 participants in 6 patient groups, including a placebo group

KLH-2109, lowest dose

Experimental group

Treatment:

Drug: Placebo

Drug: KLH-2109

KLH-2109, low dose

Experimental group

Treatment:

Drug: Placebo

Drug: KLH-2109

KLH-2109, medium dose

Experimental group

Treatment:

Drug: Placebo

Drug: KLH-2109

KLH-2109, high dose

Experimental group

Treatment:

Drug: KLH-2109

Placebo

Placebo Comparator group

Description:

First 12 week period; Placebo, Second 12 week period; randomize to one of the KLH-2109 dose levels

Treatment:

Drug: Placebo

Leuprorelin acetate

Other group

Description:

Active reference

Treatment:

Drug: Leuprorelin acetate