Effects of TAK-448 in Middle-aged and Older Men With Low Testosterone

Low Testosterone Clinical Trial

Official title: A Randomized, Single-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Stimulatory Effects of TAK-448, a Kisspeptin Analog, Administered Intermittently in Middle-aged and Older Men With Low Testosterone

Status Terminated

Clinical Trial Summary

The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to middle-aged and older men with low ST levels.

Clinical Trial Description

The drug being tested in this study is called TAK-448. TAK-448 is being tested to define a dose and dose frequency which results in a clinically relevant improvement in ST in middle-aged and older men with low ST levels. This study will look at ST levels in men who take TAK-448.

The study will enroll approximately 66 participants. Two Cohorts are planned for this study. Cohort 1 will include 3 dose groups that will run in parallel and consist of the following SC doses, 0.1 mcg once-daily, 0.3 mcg twice-weekly, and 1.0 mcg once-weekly for a period of 6 weeks. Within each dose group in Cohort 1, 11 participants will be enrolled and assigned so that 8 will receive TAK-448 and 3 will receive placebo. Cohort 2 will be enrolled after the completion of Cohort 1 and may include up to 3 dose groups. The dose and dosing frequency will be decided based on results from Cohort 1.

This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 16 weeks. Participants will make daily visits to the clinic for 8 weeks, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment. ;

Related Conditions & MeSH terms

• Low Testosterone

• NCT number: NCT02381288
• Study type: Interventional
• Source: Takeda
• Status: Terminated
• Phase: Phase 2
• Start date: September 2015
• Completion date: November 2016