CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 99 enrolled
Drug / intervention
Degarelix (GnRH antagonist) +2 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/NCT02478775
NCT02478775N/ACompleted
CompareCT.gov

Dysregulation of Follicle Stimulating Hormone (FSH) in Obesity: Functional and Statistical Analysis

University of Colorado, Denver·interventional·Posted Jun 23, 2015·Updated Jun 5, 2024

In Brief

A clinical study evaluating Degarelix (GnRH antagonist), recombinant FSH, and 1 other intervention for Obesity and Fertility. Completed, enrolled 99 participants across 1 site.

Detailed Summary

Excess maternal weight, especially obesity, influences almost every aspect of fertility, from conception to problems during pregnancy. The investigators will use novel statistical methods to clarify the hormonal changes behind reproductive health conditions. A better understanding of reproductive hormonal changes in obese women may offer a way to identify new treatments.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Fertility
CountriesUnited States
CollaboratorsNational Center for Advancing Translational Sciences (NCATS)

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 23, 2015
Enrollment StartJul 1, 2015
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 11.0 years ago

Interventions

Degarelix (GnRH antagonist)drug

Day-1: Blood samples will be obtained every 10 minutes for 10 hours. After 10 hours of blood samples have been collected, the GnRH antagonist degarelix will be given subcutaneously.

recombinant FSHdrug

Day-2: Blood samples will again be obtained every 10 minutes for 10 hours. Repeated boluses of exogenous recombinant FSH (rFSH) will be given by IV during this 10 hour visit.

Cetrorelixdrug

Day-1: Blood samples will be obtained every 10 minutes for 10 hours. After 10 hours of blood samples have been collected, the GnRH antagonist Cetrorelix will be given subcutaneously.