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

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ClinicalTrials.gov Identifier: NCT01395940
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : October 30, 2013
Sponsor:
Information provided by:
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(1)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

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

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01395940


Locations
Japan
Japan
Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsumi Hontani Kissei Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier: NCT01395940     History of Changes
Other Study ID Numbers: KLH1201
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female