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A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)

This study has been completed.
Information provided by:
Kissei Pharmaceutical Co., Ltd. Identifier:
First received: July 14, 2011
Last updated: October 29, 2013
Last verified: October 2013
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.

Condition Intervention Phase
Drug: KLH-2109
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(1)

Resource links provided by NLM:

Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

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

Estimated Enrollment: 20
Arms Assigned Interventions
Experimental: KLH-2109, lower dose Drug: KLH-2109
Experimental: KLH-2109, higher dose Drug: KLH-2109


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01395940

Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Study Director: Katsumi Hontani Kissei Pharmaceutical Co., Ltd.
  More Information Identifier: NCT01395940     History of Changes
Other Study ID Numbers: KLH1201
Study First Received: July 14, 2011
Last Updated: October 29, 2013

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

Additional relevant MeSH terms:
Genital Diseases, Female processed this record on May 25, 2017