Clinical Trial: A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Patients
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: An Open Label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious Puberty
Brief Summary: The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the treatment of Central Precocious Puberty (CPP).
Detailed Summary:
The drug being tested in this study is called leuprorelin. It is administered as a 1 month subcutaneous depot. Leuprorelin is being tested to treat children who have CPP. This study will look at the development of internal and external genital organs and appearance of secondary sexual characteristics in pre-pubertal children who take leuprorelin.
The study will enroll approximately 300 patients. Participants with body weight >=20 kg will receive the recommended dose of leuprorelin 3.75 mg subcutaneous injection every 4 weeks for 96 weeks. Participants with body weight <20 kg will receive recommended dose of 1.88 mg subcutaneous injection every 4 weeks for 96 weeks.
This trial will be conducted in China. The overall time to participate in this study is 104 weeks. Participants will make 11 visits to the clinic, and will be followed-up by the physician on a long-term basis until stable puberty is reached.
Sponsor: Takeda
Current Primary Outcome: Number of Participants Reporting One or More Treatment-emergent Adverse Events [ Time Frame: Up to Week 100 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Percentage of Participants who had Regression or no Progression in Tanner Staging [ Time Frame: Week 96 ]
Original Secondary Outcome: Same as current
Information By: Takeda
Dates:
Date Received: April 23, 2015
Date Started: August 11, 2015
Date Completion: December 31, 2018
Last Updated: April 13, 2017
Last Verified: April 2017