Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea

What Was Tested

In this not phased trial, researchers set out to test Leuprolide for sleep apnea (obstructive).

The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in women with polycystic ovary syndrome (PCOS).

It had 1 arm (groups): Depot Lupron and estrogen plus placebo (experimental).

Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive estrogen plus placebo for another 6 weeks.

The registry classes the interventions as drug.

More on the Plan

The prevalence of obesity and chronic sleep loss are at record levels among Americans and evidence continues to emerge to support a causal link between the two conditions.

While more prevalent in men, OSA is underrecognized in women in part because its clinical and polysomnographic features differ from those of men.

This study will enroll obese women with PCOS, with and without OSA.

The independent effects of androgen, estrogen, and progesterone on OSA and metabolic function will be assessed.

Who Took Part

Enrollment: 18 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Clinical diagnosis of PCOS. Obese (BMI of at least 30 kg/m2).

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: positive pregnancy test; diagnosis of diabetes mellitus; hypertension (systolic \> 140 mmhg and/or diastolic \> 90 mmhg) not well-controlled on stable medication with either ace inhibitors or diuretics.

How the Study Was Run

Design: single-group and open-label.

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

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

It started in 2007-12 with completion listed for 2022-06-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Estrogen Levels (time frame: Baseline). Sleep Efficiency Measured at Baseline (time frame: Baseline). Total Testosterone (time frame: Baseline).

It also tracked 1 secondary outcome, for example Intravenous Glucose Tolerance Test.

What This Means in Plain Language

Put simply, this is a not phased trial of Leuprolide in 18 people with sleep apnea (obstructive).

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

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

More context: the Leuprolide compound page, Sleep apnea (obstructive) research.