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Completed

NCT Number: NCT02778919

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

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients with endometriosis

Exclusion criteria

  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Treatment and study plan

KLH-2109

Drug

Placebo

Drug

Leuprorelin Acetate

Drug

Primary outcomes

  1. Change of average Numerical Rating Scale (NRS) score of pelvic pain

    Time frame: 12 weeks

Secondary outcomes

  1. Incidences of adverse events

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 20, 2016
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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