Polycystic Ovary Syndrome (PCOS) and Sleep Apnea

What Was Tested

The trial (phase 4) is built around Leuprolide for pcos and sleep apnea (obstructive).

Its onset is usually at the time of puberty with manifestations of menstrual irregularity, hirsutism, and obesity.

Women with PCOS suffer at an early stage of adulthood from all of the components of the metabolic syndrome, a syndrome that typically has its peak in mid-life in other subject populations.

It had ten arms (groups): Aim 1: Placebo (no intervention), Aim 1: Pioglitazone (experimental), Aim 1: Leuprolide + Estrogen/Progestin (experimental), Aim 2: PCOS + SDB (experimental) and Aim 2: Matched Controls (experimental).

One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.

One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.

One of the 3 treatment arms in Aim 1: depot leuprolide plus estrogen/progestin replacement. No subjects were randomized to this arm.

The registry classes the interventions as device, drug and procedure.

More on the Plan

PCOS presents a unique opportunity to dissect the relationship between metabolic and cardiovascular risk and sleep disordered breathing (SDB) in a population where intrinsic effects of aging have not yet developed.

Because a relationship between obstructive sleep apnea, insulin resistance and elevated testosterone levels has also been observed in men and in women without PCOS, insights gained from studies in PCOS will have broad implications.

The Specific Aims of the present application are: Specific Aim 1: to test the hypothesis that sleep disturbances are caused by hyperandrogenemia and hyperinsulinemia that characterize PCOS.

Following a detailed baseline evaluation of sleep, hormonal, metabolic and cardiovascular parameters, women with PCOS will be randomized to an 8-week treatment phase with pioglitazone or depot leuprolide plus estrogen/progestin replacement or placebo.

Who Took Part

Enrollment: 37 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: The presence of oligo/amenorrhea;. Hyperandrogenemia, defined by a supranormal plasma free testosterone level (\> 10 pg/ml);. Hyperandrogenism, as evidenced by infertility, hirsutism, acne, or androgenetic alopecia; and.

The full record lists 7 inclusion and 1 exclusion criteria.

How the Study Was Run

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

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

The Leuprolide group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant and care provider.

It started in 2003-09 with completion listed for 2008-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Aim 1: Apnea-Hypopnea Index (AHI) [Baseline] (time frame: baseline). Aim 1: Apnea-hypopnea Index (AHI) [After Treatment] (time frame: 8 weeks). Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline] (time frame: baseline (0 weeks)).

It also tracked 8 secondary outcomes, for example Aim 1: Visceral Adiposity [Baseline], Aim 1: Visceral Adiposity [After Treatment], Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [Baseline], Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [After Treatment], Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [Baseline] and Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [After Treatment].

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 37 people with pcos.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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