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A Randomized, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01533532
First Posted: February 15, 2012
Last Update Posted: May 30, 2014
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.
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
  Purpose
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.

Condition Intervention Phase
Endometriosis Drug: KLH-2109 Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-controlled, Double-blind Phase II Study of KLH-2109 in Patients With Endometriosis(2)

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: 12 weeks ]

Estimated Enrollment: 100
Arms Assigned Interventions
Experimental: KLH-2109, low dose Drug: KLH-2109
Experimental: KLH-2109, medium dose Drug: KLH-2109
Experimental: KLH-2109, high dose Drug: KLH-2109
Placebo Comparator: placebo Drug: placebo

  Eligibility

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
  Contacts and Locations
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): NCT01533532


Locations
Japan
Japan
Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Tatsuro Takei Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01533532     History of Changes
Other Study ID Numbers: KLH1202
First Submitted: February 12, 2012
First Posted: February 15, 2012
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:
Endometriosis
Genital Diseases, Female