NCT02381288

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Takeda · Industry
• Sex: Male
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug tested in this study is called TAK-448. TAK-448 was 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 looked at ST levels in men who took TAK-448. The study enrolled 17 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the following treatment groups-which remained undisclosed to the participants and study doctor during the study (unless there is an urgent medical need): * TAK-448 0.1 µg * TAK-448 0.3 µg * TAK-448 1.0 µg * Placebo (dummy inactive injection) - this was a injection that looks like the study drug but has no active ingredient All participants received subcutaneous injection either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36. This single-center trial was conducted in the United States. The overall time to participate in this study is up to 56 days. Participants made daily visits to the clinic for 8 weeks, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Conditions

• Low Testosterone

Interventions

Type	Name	Description
DRUG	TAK-448	TAK-448 solution for subcutaneous injection
DRUG	TAK-448 Placebo	TAK-448 placebo-matching solution for subcutaneous injection

Timeline

• Start date: 2015-09-10
• Primary completion: 2016-04-08
• Completion: 2016-04-08
• First posted: 2015-03-06
• Last updated: 2017-05-17
• Results posted: 2017-05-17

Locations

1 site across 1 country: United States