Conditions: Low Testosterone
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: no

Brief 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.

Arms:
arm 1: TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42. arm 2: TAK-448 0.3 mcg, injection, subcutaneously, twice-weekly on Days 1 through 39. arm 3: TAK-448 1.0 mcg, injection, subcutaneously, once-weekly on Days 1 through 36. arm 4: TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.

Interventions: intervention 1: TAK-448 intervention 2: TAK-448 Placebo
Intervention descriptions: intervention 1: TAK-448 solution for subcutaneous injection intervention 2: TAK-448 placebo-matching solution for subcutaneous injection

Protocol document: