A Study to Evaluate Pharmacokinetics, Pharmacodynamics and Tissue Concentrations of Epelsiban

What Was Tested

In this phase 1 trial, researchers set out to test Oxytocin.

Additionally tissues concentrations of epelsiban will be determined from endometrial tissue biopsies.

It had three arms (groups): Oxytocin or Placebo challenge (Cohort 1) (experimental), Epelsiban or Placebo (Cohort 2) (experimental) and Biopsy cohort (Cohort 3) (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 33 actual participants took part.

It was open to women only aged from 18 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Female volunteers of childbearing potential; with a negative pregnancy test as determined by human chorionic gonadotropin (hCG) testing at screening and prior to study initiation. Age between 18 and 35 years old (inclusive). Body weight \>=50 kilograms (kg) and body mass index (BMI) within the range 18-30 kg/meter (m)\^2 (inclusive). Normal ovarian and uterine anatomy as assessed by transvaginal ultrasonography. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

The full record lists 11 inclusion and 28 exclusion criteria; among the exclusions: pregnancy (suspected or diagnosed) or lactation; has had a prior partial or total hysterectomy or tubal ligation; currently using and intrauterine device (iud) for any reason.

How the Study Was Run

Design: randomized, single-group and double-blind.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and investigator.

It started in 2014-08-28 with completion listed for 2016-02-07.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Frequency of endometrial contractions in Cohorts 2A, 2B and 2C during the periovulatory phase and 3-5 days post ovulation (time frame: Up to Day 2).

It also tracked 15 secondary outcomes, for example Frequency of endometrial and subendometrial contractility in Cohort 2, Frequency of subendometrial contractility in Cohort 3, Number of subjects with adverse events in Cohort 1, Number of subjects with adverse events (AEs) in Cohort 2, Number of subjects with adverse events in Cohort 3 and Change from Baseline in laboratory parameters in Cohort 1.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 33 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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