Psychological Outcomes in Isolated GnRH Deficiency

Stopped early

Conditions studied: Hypogonadism

In brief

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.

Key facts

Study ID

NCT02356172

Run by

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

People needed

48

Starts

2015-02-04

Expected to finish

2019-07-16

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older, up to 200. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females with clinical findings consistent with IGD who are greater than or equal to 18 years old and treated with hormone replacement therapy for IGD at the full adult replacement dose for at least 3 months. Clinical findings of IGD will be confirmed by a nurse or physician associated with this protocol, and include: clinical presentation consistent with a diagnosis of IGD, such as delayed, incomplete, or absent pubertal development, and a record of serum hormone levels demonstrating low total testosterone (males) or estradiol (females) in association with low or inappropriately normal gonadotropin levels in a clinic note or history and physical, and individuals with records demonstrating failure to undergo normal puberty. Anosmia may or may not be present. Since IGD presents as a phenotypic spectrum, there are no specific exclusion criteria for this study, except as noted below.

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 who do not have a diagnosis of IGD as indicated by the inclusion criteria above;
• 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:
• INCLUSION CRITERIA:
• Healthy males or females who are greater than or equal to 18 years old.
• EXCLUSION CRITERIA:
• 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.

Where it is running

• National Institute of Child Health and Human Development (NICHD), 9000 Rockville — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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