Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS

What Was Tested

This registered early phase 1 trial tested Cosyntropin for pcos.

The objective of the study is to determine the relative contributions of four established predictors of hyperandrogenism (luteinizing hormone \[LH\] secretion, ovarian response to recombinant human chorionic gonadotropin \[r-hCG\] administration, adrenal response to adrenocorticotropic hormone \[ACTH\] administration, and hyperinsulinemia) in older vs. young women with Polycystic Ovary Syndrome (PCOS) in a cross-sectional, physiological study.

The investigators hypothesize that hyperinsulinemia is a stronger independent predictor of free testosterone (T) in older reproductive aged (vs. young) women with PCOS.

It had 1 arm (groups): ACTH (Cosyntropin), rhCG (Ovidrel) (experimental).

The registry classes the interventions as drug.

More on the Plan

PCOS is a highly prevalent reproductive disorder characterized by hyperandrogenism (HA) and oligo/anovulation.

In young women with PCOS, several factors contribute to HA: a) excess LH secretion, b) abnormal ovarian steroidogenesis, c) abnormal adrenal steroidogenesis, and d) hyperinsulinemia/ insulin resistance.

However, the relative contributions of the aforementioned HA-related factors in young adult vs. late reproductive-aged women with PCOS are not known.

Identifying the most important predictor(s) of HA in older women with PCOS will be critically important for devising the most relevant therapeutic strategies for older women with PCOS.

Who Took Part

Enrollment: 144 planned participants were the target.

It was open to women only aged from 20 years up to 49 years.

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

Examples of who could join: Screening safety labs within normal reference ranges although mild abnormalities that are common in obesity and/or hyperandrogenism will not be grounds for exclusion (see.

The full record lists 2 inclusion and 35 exclusion criteria; among the exclusions: subjects must be willing and able to provide written informed consent; willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of the study; willingness and ability to comply with scheduled visits and study procedures.

How the Study Was Run

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

Nothing was hidden in this open-label Cosyntropin study: the pcos participants and staff both knew the treatment.

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

It started in 2019-10-08 with completion listed for 2026-04-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change in calculated free testosterone concentrations. Mean luteinizing hormone (LH) concentrations (time frame: overnight frequent blood sampling (every 10 mininutes for 12 hours)). Change in ovarian 17-hydroxyprogesterone to r-hCG (time frame: baseline, and 24 hours after receiving rhCG).

It also tracked 6 secondary outcomes, for example Matsuda index, LH pulse frequency, Change in dehydroepiandrosterone (DHEA) to r-hCG, Change in DHEA to ACTH, Change in androstenedione to r-hCG and Change in androstenedione to ACTH.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Cosyntropin in 144 people with pcos.

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

More context: the Cosyntropin compound page, PCOS research.