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

Kissei logo

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems