Detailed Clinical, Biochemical and Genetic Characterization in Gonadotropin-releasing Hormone (GnRH) Deficiency Disorders

Hypothalamic Amenorrhea Clinical Trial

Official title:

Detailed Clinical, Biochemical and Genetic Characterization in GnRH Deficiency Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01165619
• Other study ID #: 1200204347-BL
• Status: Terminated
• Phase: N/A
• First received: July 16, 2010
• Last updated: May 23, 2011
• Start date: June 2010
• Est. completion date: October 2010

Study information

• Verified date: May 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Amenorrhea
• Hypogonadism
• Hypothalamic Amenorrhea
• Idiopathic Hypogonadotropic Hypogonadism

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum/plasma markers	At the study visit, serum and plasma samples will be taken to measure levels of reproductive hormones and metabolic markers in the subjects' blood.	baseline	No
Secondary	Genetics	At the study visit, blood will be taken and DNA cell lines will be made to screen for genes that potentially contribute to the development of reproductive disorders	baseline	No