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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01533532
First received: February 12, 2012
Last updated: May 29, 2014
Last verified: May 2014
  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:


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
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, see Learn About Clinical Studies.

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 29, 2014
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 October 23, 2014