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

• Sponsor: Kissei Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02778919
• Collaborator: (none)
• Location: 1
• Arms: 6
• Actual Duration (Months): 22.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: KLH-2109; Drug: Placebo; Drug: Leuprorelin acetate	Phase 2

Study Design

• Study Type: Interventional
• Actual Study Start Date: May 9, 2016
• Actual Primary Completion Date: Mar 23, 2018
• Actual Study Completion Date: Mar 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KLH-2109, lowest dose	Drug: KLH-2109; Drug: Placebo
Experimental: KLH-2109, low dose	Drug: KLH-2109; Drug: Placebo
Experimental: KLH-2109, medium dose	Drug: KLH-2109; Drug: Placebo
Experimental: KLH-2109, high dose	Drug: KLH-2109
Placebo Comparator: Placebo First 12 week period; Placebo, Second 12 week period; randomize to one of the KLH-2109 dose levels	Drug: Placebo
Other: Leuprorelin acetate Active reference	Drug: Leuprorelin acetate

Outcome Measures

Primary Outcome Measures

1. Change of average Numerical Rating Scale (NRS) score of pelvic pain [12 weeks]

Secondary Outcome Measures

1. Incidences of adverse events [24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female patients with endometriosis

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Multiple Locations		Japan

Sponsors and Collaborators

• Kissei Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kissei Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02778919
• Other Study ID Numbers: KLH1204
• First Posted: May 20, 2016
• Last Update Posted: Jun 4, 2019
• Last Verified: Jun 1, 2019

• Keywords provided by Kissei Pharmaceutical Co., Ltd.: Endometriosis
• Additional relevant MeSH terms: Endometriosis; Leuprolide

Study Results

No Results Posted as of Jun 4, 2019