Sustained exposure to the investigational Kisspeptin analog, TAK-448, down-regulates testosterone into the castration range in healthy males and in patients with prostate cancer: results from two phase 1 studies

What Was Tested

The paper reports a study of Kisspeptin-10, published as a randomized controlled trial.

Kisspeptin-54, an endogenous naturally occurring ligand of the G protein-coupled receptor-54, stimulates GnRH-gonadotropin secretion and suppresses metastases in animal models of cancer but is subject to rapid degradation and inactivation.

TAK-448 is an investigational oligopeptide analog of the fully active 10-amino acid C terminus of kisspeptin-54.

Who Took Part

The abstract describes 448 subjects taking part.

PubMed indexes the participants as adults, middle-aged adults and older adults, men only.

In a subsequent, open-label, phase 1 study in PC patients aged 40-78 years, TAK-448 was given as a 1-month depot formulation.

How the Study Was Run

The design is described as randomized, open-label and placebo-controlled.

Because people in this Kisspeptin-10 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Nothing was hidden in this open-label Kisspeptin-10 study: the subjects and staff both knew the treatment.

The comparison arm used a placebo, so changes seen with Kisspeptin-10 could be set against what happens without it.

What Was Measured

PubMed files the paper under topics including Down-Regulation, Drugs, Investigational, Health, Kisspeptins, Luteinizing Hormone, Orchiectomy and Prostatic Neoplasms.

What This Means in Plain Language

The paper is a randomized, open-label and placebo-controlled study of Kisspeptin-10 in 448 subjects.

With several hundred people or more, it is a fairly large study for this kind of research.

Its findings take up roughly 9 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2014 (The Journal of clinical endocrinology and metabolism), a journal based in United States.

More context: the Kisspeptin-10 compound page, all human trials.