Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation

What Was Tested

This registered not phased trial tested Cosyntropin.

Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much facial and body hair, and weight gain.

Women with PCOS also have a hard time becoming pregnant.

Girls with high levels of the male hormone testosterone often develop PCOS as adults.

It had 1 arm (groups): Dexamethasone, Cortrosyn (experimental).

The registry classes the interventions as drug.

More on the Plan

The researchers propose that the adrenal gland is the predominant source of the early morning rise in progesterone and testosterone which is more marked in early puberty.

The researchers will explore the hypothesis that functional adrenal hyperandrogenism, or ACTH hyperresponsiveness, is one mechanism underlying this excess adrenal androgen production seen in obesity.

Who Took Part

Enrollment: 84 planned participants were the target.

It was open to women only aged from 7 years up to 18 years.

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

Examples of who could join: Normal and obese (\>95th BMI%) females. Weight of 24 kg or more. Early to late puberty (expected age range 7-18).

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: screening labs outside of age-appropriate normal range; 17-hydroxyprogesterone \>295 ng/dl; weight\<24 kg.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Cosyntropin 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 2006-10-10 with completion listed for 2024-08-27.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.

It also tracked 2 secondary outcomes, for example Overnight changes in male and female hormones in response to ACTH suppression and Response to ACTH stimulation in normal weight and overweight girls.

What This Means in Plain Language

Put simply, this is a not phased trial of Cosyntropin in 84 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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