Psychological Outcomes in Isolated GnRH Deficiency

NCT02356172 | Terminated

• 2 other identifiers: 99991507715-CH-N077
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Isolated (or Congenital) GnRH Deficiency (IGD) is a rare disease. People who have this go through puberty late. Some never reach puberty or don t complete it without treatment. They also may have an impaired sense of smell or other health problems. Research shows that disorders like this can have a negative effect on a person s psychological profile. Objective: \- To understand the psychological outcomes in people with IGD. These can include depression, anxiety, poor health, and poor social function. Eligibility:

• Adults age 18 and over with IGD. They must be currently on a full dose of hormone replacement therapy for at least 3 months.
• Healthy adult volunteers. Design:
• Participants will get a username and password. This will give them access to questions online. They can do this from any computer connected to the Internet.
• Participants will log in and complete the questionnaires. There are 5 total, but they will appear as 1 continuous set of questions. Answering them takes about 1 hour or less.
• The first set is about the participant s disorder. The rest ask about depression, anxiety, global health, and social function.
• All answers will be used for research and to better understand reproductive disorders. Only researchers from the NIH Unit on Genetics of Puberty and Reproduction and from this study will know which answers belong to which participant.

Conditions

Hypogonadism

Keywords

Quality of Life; Depression; Kallmann Syndrome; Hypogonadotropic Hypogonadism

Outcome Measures

Primary Outcomes (1)

• The primary outcome is to identify whether patients with Isolated GnRH Deficiency have a higher prevalence of negative emotional states, including depression, anxiety, poor social function and quality of life, than healthy controls.

  In analysis phase

  At enrollment

Study Arms (2)

Healthy Controls

Healthy males or females who are greater than or equal to 18 years old.

Patients

Males or females with a diagnosis of IGD (Isolated GnRH Deficiency) who are greater than or equal to 18 years old.

Eligibility Criteria

• Age: 18 Years - 200 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with a diagnosis of IGD who are \<18 years old;
• Patients with a diagnosis of IGD who are not on a full adult replacement dose of sex hormone therapy for at least 3 months;
• Patients without access to a computer connected to the internet;
• Patients who cannot read, write, and understand English at an eighth grade level or above.
• ELIGIBILITY CRITERIA FOR HEALTHY CONTROLS:
• Healthy males or females who are greater than or equal to 18 years old.
• Subjects with any chronic medical condition, other than seasonal/environmental allergies;
• Subjects with a BMI \< 18.5 or \> 29.9;
• Subjects with prior history of abnormal pubertal development, infertility, or anosmia;
• Subjects with a family history of IGD;
• Subjects without access to a computer connected to the internet;
• Subjects who cannot read, write, and understand English at an eighth grade level or above.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institute of Child Health and Human Development (NICHD), 9000 Rockville

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Hypogonadism; Depression; Kallmann Syndrome

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Behavioral Symptoms; Behavior; Disorder of Sex Development, 46,XY; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Angela Delaney Freedman, M.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 5, 2015
• Study Start: February 4, 2015
• Primary Completion: June 1, 2017
• Study Completion: July 16, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07-16

Locations

US (1)