Pharmacokinetics, Safety, and Tolerability of Multiple Doses of the Novel Oxytocin Receptor Antagonist Cligosiban in Development for Premature Ejaculation: Two Randomized Clinical Trials in Healthy Subjects

What Was Tested

The paper reports a study of Oxytocin, published as a randomized controlled trial.

Cligosiban (formerly IX-01) is a selective oxytocin receptor antagonist being developed for the treatment of premature ejaculation (PE).

Toleration of cligosiban will need to be confirmed in studies in patients with PE.

Who Took Part

According to the abstract, 12 subjects were involved.

The age groups tagged for this paper are teenagers, young adults, adults and middle-aged adults, both men and women.

Both studies were double-blind, placebo-controlled, parallel group designs involving sequential cohorts of 12 subjects each.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and parallel-group study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Blinding on both sides kept the subjects and researchers unaware of who received Oxytocin.

A placebo (an inactive look-alike) gave the Oxytocin group a baseline to be compared against.

Groups ran in parallel: each of the subjects stayed in one arm throughout.

What Was Measured

Topics PubMed links to this paper include Healthy Volunteers, Premature Ejaculation, Pyridines, Receptors, Oxytocin and Triazoles.

The authors tagged it with the keywords Cligosiban, IX-01, Oxytocin Receptor Antagonist and Tolerability.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Oxytocin in 12 subjects.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Its findings take up roughly 16 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2019 (The journal of sexual medicine), a journal based in Netherlands.

More context: the Oxytocin compound page, all human trials.