A Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01629420
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : May 30, 2014
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Endometriosis Drug: KLH-2109 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(3)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Drug:KLH-2109 lower dose Drug: KLH-2109
Experimental: Drug:KLH-2109 higher dose Drug: KLH-2109

Primary Outcome Measures :
  1. The severity score of the pelvic pain [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01629420

Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.

Responsible Party: Kissei Pharmaceutical Co., Ltd. Identifier: NCT01629420     History of Changes
Other Study ID Numbers: KLH1203
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Gonadotropin-Releasing Hormone (GnRH) antagonist

Additional relevant MeSH terms:
Genital Diseases, Female