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

Kissei

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: placebo; Drug: KLH-2109

Study type: Interventional

Funder types: Industry

Identifiers

NCT01533532

KLH1202

Details and patient eligibility

About

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

KLH-2109, low dose

Experimental group

Treatment:

Drug: KLH-2109

Drug: KLH-2109

Drug: KLH-2109

KLH-2109, medium dose

Experimental group

Treatment:

Drug: KLH-2109

Drug: KLH-2109

Drug: KLH-2109

KLH-2109, high dose

Experimental group

Treatment:

Drug: KLH-2109

Drug: KLH-2109

Drug: KLH-2109

placebo

Placebo Comparator group

Treatment:

Drug: placebo