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Late Phase II Clinical Study of KLH-2109 in Patients With Endometriosis

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.
 
ClinicalTrials.gov Identifier: NCT02778919
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the efficacy, safety, and dose-response relationship of KLH-2109 compared to placebo in Japanese patients with endometriosis.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: KLH-2109 Drug: Placebo Drug: Leuprorelin acetate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Study Start Date : May 9, 2016
Actual Primary Completion Date : March 23, 2018
Actual Study Completion Date : March 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: KLH-2109, lowest dose Drug: KLH-2109
Drug: Placebo
Experimental: KLH-2109, low dose Drug: KLH-2109
Drug: Placebo
Experimental: KLH-2109, medium dose Drug: KLH-2109
Drug: Placebo
Experimental: KLH-2109, high dose Drug: KLH-2109
Placebo Comparator: Placebo
First 12 week period; Placebo, Second 12 week period; randomize to one of the KLH-2109 dose levels
Drug: Placebo
Leuprorelin acetate
Active reference
Drug: Leuprorelin acetate



Primary Outcome Measures :
  1. Change of average Numerical Rating Scale (NRS) score of pelvic pain [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Incidences of adverse events [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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): NCT02778919


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02778919    
Other Study ID Numbers: KLH1204
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Endometriosis
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents