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Psychological Outcomes in Isolated GnRH Deficiency

NCT02356172 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2019-07-18

No results posted yet for this study

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

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Angela Delaney Freedman, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility

Min Age
18 Years
Max Age
200 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-04
Primary Completion
2017-06-01
Completion
2019-07-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02356172 on ClinicalTrials.gov