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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01533532
First received: February 12, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

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

Primary Outcome Measures:
  • The severity score of the pelvic pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01533532     History of Changes
Other Study ID Numbers: KLH1202
Study First Received: February 12, 2012
Last Updated: May 6, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013