CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Cetrorelix +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01457703
NCT01457703N/ACompleted

Reproductive Hormonal Alterations in Obesity, AIMS #1 & #2

University of Colorado, Denver·interventional·Posted Oct 24, 2011·Updated Jan 12, 2017

In Brief

A clinical study evaluating Cetrorelix, Gonadorelin-GnRH, and 2 other interventions for Obesity. Completed, enrolled 62 participants across 1 site.

Detailed Summary

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. Women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will be examined. --Hypotheses: 1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese compared to normal weight women) 2. Obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 24, 2011
Enrollment StartJun 1, 2010
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.7 years ago

Interventions

Cetrorelixdrug

Abolishes pituitary sensitivity to GnRH.

Gonadorelin-GnRHdrug

GnRH is used to stimulate the pituitary gland to produce LH and FSH.

Recombinant LHdrug

Used to stimulate ovarian function in women.

Letrozoledrug

An aromatase inhibitor.