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Clinical Trials/NCT01165619
NCT01165619
Terminated
Not Applicable

Detailed Clinical, Biochemical and Genetic Characterization in GnRH Deficiency Disorders

Massachusetts General Hospital1 site in 1 country50 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Idiopathic Hypogonadotropic Hypogonadism
Sponsor
Massachusetts General Hospital
Enrollment
50
Locations
1
Primary Endpoint
Serum/plasma markers
Status
Terminated
Last Updated
14 years ago

Overview

Brief Summary

In this study, we will measure levels of reproductive hormones and metabolic markers in subjects with isolated GnRH deficiency disorders and compare them to healthy control populations. Our goals are (1) to chart the range of hormonal and metabolic biomarkers in healthy subjects and those with reproductive disorders and (2) to correlate reproductive and metabolic phenotypes with genetic changes within patients with reproductive disorders and healthy controls.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
October 2010
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Over the age of 18 for men
  • Between the ages of 18 and 40 for women
  • For reproductive disorder population: Current or previous diagnosis of Idiopathic Hypogonadotropic Hypogonadism or Hypothalamic Amenorrhea

Exclusion Criteria

  • chronic disease (hypertension, high cholesterol, diabetes, asthma, etc)
  • polycystic ovarian syndrome for women
  • prescription medication use (other than allergy meds) for control populations
  • irregular menstrual cycles for healthy female control population (cycle length longer than 35 days or shorter than 25 days. cycle length varies by more than 5 days. less than 9 periods per year)

Outcomes

Primary Outcomes

Serum/plasma markers

Time Frame: baseline

At the study visit, serum and plasma samples will be taken to measure levels of reproductive hormones and metabolic markers in the subjects' blood.

Secondary Outcomes

  • Genetics(baseline)

Study Sites (1)

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