Reproductive Hormonal Alterations in Obesity

What Was Tested

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

The purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight.

The proposal will examine the reproductive system at the level of the brain and the ovary to define the changes that happen leading to lowered hormone production.

It had two arms (groups): BMI ≥30 kg/m2 (active comparator) and BMI 18-25 kg/m2 (experimental).

Group 2: * BMI ≥30 kg/m2 * History of regular menstrual cycles every 25-40 days Gonadorelin-GnRH (Lutrepulse), GnRH antagonists - Cetrorelix (Cetrotide), Recombinant LH (Luveris) were administered in Aim 1. GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2.

* BMI 18-25 kg/m2 * History of regular menstrual cycles every 25-35 days Gonadorelin-GnRH (Lutrepulse), GnRH antagonists - Cetrorelix (Cetrotide), Recombinant LH (Luveris) were administered in Aim 1. GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 62 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Aged 18-40 at study entry. BMI either 18-25 kg/m2 or ≥30 kg/m2. Prolactin (PRL) and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening. Baseline hemoglobin \>11 gm/dl. History of regular menstrual cycles every 25-35 days if BMI 18-25 kg/m2.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: history of chronic disease affecting hormone production, metabolism or clearance; use of medications that are known to alter or interact with reproductive hormones (e.g., thiazolidinediones, metformin); use of hormones within three months of enrollment.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

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

Being open-label, the Gonadorelin study did not mask who received what.

It started in 2010-06 with completion listed for 2013-07.

It ran at 1 site in United States.

What Was Measured

The main thing measured (primary outcome): Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1) (time frame: Measured hourly and averaged over the 12 hour study visit). Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2) (time frame: Measured hourly and averaged over the 12 hour study visit). Changes in Pregnanediol Glucuronide (PdG) (Aim 2) (time frame: Averaged over the length of menstrual cycle).

It also tracked 2 secondary outcomes, for example Changes in Follicle Stimulating Hormone (FSH) (Aim 1) and Changes in Follicle Stimulating Hormone (FSH) (Aim 2).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Gonadorelin and Cetrorelix in 62 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Gonadorelin compound page and the Cetrorelix compound page, all human trials.