Estrogen Sensitivity and Ovulatory Dysfunction in Obesity

What Was Tested

In this not phased trial, researchers set out to test Gonadorelin.

The sole purpose of this study is to evaluate pathophysiology of disease.

The disease state that is being evaluated is the obesity-related alterations in reproductive hormones * The obesity epidemic in the United States is advancing at an accelerated pace.

It had two arms (groups): Group 1 - Normal Weight (other) and Group 2 - Obese (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 30 actual participants took part.

It was open to women only aged from 18 years up to 42 years.

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

Examples of who could join: Age 18-42 at study entry. Regular menstrual cycles every 25-40 days. BMI 18- 25 kg/m2 or ≥30kg/m2. Good general health. Prolactin and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: positive screen for activated protein c resistance; current use of thiazolidinediones or metformin (known to interact with reproductive hormones); use of hormones affecting hypothalamic-pituitary ovarian axis within three months of enrollment.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2011-06 with completion listed for 2013-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Luteinizing Hormone Pulse Amplitude (time frame: Baseline). Luteinizing Hormone Pulse Amplitude (time frame: Post estradiol at one month).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Gonadorelin in 30 people.

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 Gonadorelin compound page, all human trials.