Pharmacokinetics, Safety, and Tolerability of Single Oral Doses of a Novel Oxytocin Receptor Antagonist-Cligosiban-in Development for Premature Ejaculation: Three Randomized Clinical Trials in Healthy Subjects

What Was Tested

This randomized controlled trial paper looks at Oxytocin.

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

Cligosiban in CSF indicates its likely presence in all central nervous system tissue.

Who Took Part

The study group was 3 subjects.

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

Study 1 was a double-blind, randomized, placebo-controlled, crossover design in 3 cohorts of 10 subjects each.

Studies 2 and 3 were open-label, randomized, crossover designs in 12 subjects each.

How the Study Was Run

In design terms this was a randomized, double-blind, open-label, placebo-controlled and crossover study.

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

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

Being open-label, the Oxytocin study did not mask who received what.

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

What Was Measured

PubMed files the paper under topics including Area Under Curve, Healthy Volunteers, Premature Ejaculation, Pyridines, Receptors, Oxytocin and Triazoles.

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

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Oxytocin in 3 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.

Results are reported in around 12 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2018 (The journal of sexual medicine), a journal based in Netherlands.

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