Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)

What Was Tested

In this phase 3 trial, researchers set out to test hCG (human chorionic gonadotropin) for pcos.

The investigators hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal women.

It had two arms (groups): PCOS group (active comparator) and Control group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Each subject (normal and PCOS women) will be admitted to the UCSD General Clinical Research Center (GCRC) for study on 5 occasions.

Blood samples will be obtained at t -0.5, 0, and 24 hours after injection.

All visits to the GCRC will be done as out patients.

The total amount of blood withdrawn will be about 35 teaspoons.

Who Took Part

The registry lists 25 actual participants took part.

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

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

Examples of who could join: Normal renal and liver function tests. Normal vital signs including normal blood pressure.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: no oral contraceptives; no insulin lowering drugs; no anti-androgens (i.e., spironolactone, flutamide, finasteride, etc).

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Everyone knew when hCG (human chorionic gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-09 with completion listed for 2010-04.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Serum 17OHP Responses to hCG.

It also tracked 1 secondary outcome, for example Serum Testosterone Responses to hCG.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of hCG (human chorionic gonadotropin) in 25 people with pcos.

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 hCG (human chorionic gonadotropin) compound page, PCOS research.