Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

What Was Tested

In this phase 2 trial, researchers set out to test Elagolix (non-peptide).

This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).

It had six arms (groups): Placebo (placebo comparator), one (experimental), one (experimental), one (experimental) and one (experimental).

Placebo taken orally twice a day (BID).

The registry classes the interventions as drug.

More on the Plan

PCOS is one of the most common hormonal disorders in women of reproductive age, yet few treatment options are available.

Who Took Part

118 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants with clinical diagnosis of PCOS. Participants with a body mass index (BMI) of 18.5 to 38 kg/m\^2 at time of Screening.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: participants with newly diagnosed medical condition requiring intervention that has not been stabilized at least 30 days prior to baseline.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Elagolix (non-peptide) and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Elagolix (non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2019-08-12 with completion listed for 2021-02-10.

It ran at 54 sites in United States (50) and Puerto Rico (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Menstrual Cycle Responders (time frame: Week 0 (Baseline) to Week 24 (Month 6)).

It also tracked 1 secondary outcome, for example Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Elagolix (non-peptide) in 118 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Elagolix (non-peptide) compound page, all human trials.